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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1 BRU07100001P Augmentin Injection 1.2g Co-Amoxiclav 1000/200 -
Amoxicillin 1g as sodium salt,
clavulanic acid 200mg as potassium
salt
SmithKline Beecham PLC,
Worthing, West Sussex, UK
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
2 BRU07100002P Augmentin Injection 600mg Co-Amoxiclav 500/100 - Amoxicillin
500mg as sodium salt, clavulanic
acid 100mg as potassium salt
SmithKline Beecham PLC,
Worthing, West Sussex, UK
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
3 BRU08010001P Pharmaniaga Aciclovir Tablet
200mg
Aciclovir 200mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
4 BRU08010002P Pharmaniaga Ketoconazole
Tablet 200mg
Ketoconazole 200mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
5 BRU08010003P Pharmaniaga Clarithromycin
Tablet 250mg
Clarithromycin 250mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
6 BRU08010004P Pharmaniaga Fluconazole
150mg Capsules
Fluconazole 150mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
7 BRU08010005P Pharmaniaga Ciprofloxacin
Tablet 500mg
Ciprofloxacin 500mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
8 BRU08020012P Pharmaniaga Cephalexin
Capsule 500mg
Cephalexin 500mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
9 BRU08020013P Pharmaniaga Metronidazole
Tablet 200mg
Metronidazole 200mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
10 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
11 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
12 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
13 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
14 BRU08020020P Diprivan 10mg/ml (1%)
Emulsion for Injection or
Infusion (20ml Ampoule)
Propofol 10mg/ml (1%) Corden Pharma S.P.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 1 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
15 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate);
Clavulanic acid 125mg (as
Potassium Clavulanate)
SmithKline Beecham Plc,
Worthing, UK
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
16 BRU08030024P Augmentin Syrup 228mg/5ml Amoxycillin 200mg/5ml (as
trihydrate); Clavulanic acid
28.5mg/5ml (as Potassium
Clavulanate)
SmithKline Beecham Plc,
Worthing, UK
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
17 BRU08030025P Augmentin Syrup 457mg/5ml Amoxycillin 400mg/5ml (as
trihydrate); Clavulanic acid
57mg/5ml (as Potassium
Clavulanate)
SmithKline Beecham Plc,
Worthing, UK
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
18 BRU08030026P Augmentin Tablet 1g Amoxycillin 875mg (as trihydrate);
Clavulanic acid 125mg (as
Potassium Clavulanate)
SmithKline Beecham Plc,
Worthing, UK
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
19 BRU08030027P Foban Cream Fusidic acid 2% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
20 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 October 2015 till 05
October 2020
POM
21 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
22 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium) GlaxoSmithKline Manufacturing
SPA, Italy.
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
23 BRU08030035P Zinacef Injection 1.5g Cefuroxime (as sodium) GlaxoSmithKline Manufacturing
SPA, Italy.
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
24 BRU08030036P Zinnat Tablet 125mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
25 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
26 BRU08040040P Retrovir Syrup Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
27 BRU08040041P Zeffix Tablet Lamivudine 100mg GlaxoSmithKline Pharmaceuticals
S.A., Poland
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
28 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine
300mg
GlaxoSmithKline Pharmaceuticals
S.A., Poland
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
29 BRU08040043P Zoraxin Suspension Aciclovir 200mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
120ml
BDMCA/RMP/0319 Page 2 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
30 BRU08040045P Apalin Solution for Injection Amikacin Sulphate 500mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
31 BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
32 BRU08040049P Diflucan IV Infusion 2mg/ml
(50ml)
Fluconazole 2mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
33 BRU08040050P Sulperazone IM/IV 1g Sulbactam (as Sodium) 500mg;
Cefoperazone (as Sodium) 500mg
Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
34 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2% Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
35 BRU08050053P Pharmaniaga Aciclovir Tablet
400mg
Aciclovir 400mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
36 BRU08050054P Pharmaniaga Cephalexin
Capsule 250mg
Cephalexin (as Anhydrous)
Cephalexin 250mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
37 BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
38 BRU08050061P Unocef Injection 1000mg
(Vial)
Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
39 BRU08050062P Garasent 280mg Injection
(2ml Ampoule)
Gentamicin (as Sulphate BP)
280mg
Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
40 BRU08050065P Beavate-N Cream Betamethasone-17-valerate
equivalent to Betamethasone
0.1%w/w; Neomycin Sulphate
0.5%w/w
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
41 BRU08050066P Beagenta Eye/ Ear Drops Gentamicin Sulphate equivalent to
Gentamicin 0.3%w/w
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
42 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg
(micronised)
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
43 BRU08050070P Betacin Eye Ear Drop Neomycin Sulphate 0.5% w/v;
Betamethasone Sodium Phosphate
0.1%w/v
Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 October 2015 till 05
October 2020
POM
44 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/v Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
45 BRU08050072P Fobancort Cream Fusidic acid 2%w/w;
Betamethasone Dipropionate
0.064%w/w equivalent to
Betamethasone 0.05%w/w
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 3 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
46 BRU08050073P Dezor Cream Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
47 BRU08050074P Dezor Shampoo Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
48 BRU08060075P Genta-Dex Eye Drops Gentamicin 0.3% w/v;
Dexamethsone Phosphate
0.1%w/v
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
49 BRU08060077P Aecoras Ointment Econazole Nitrate 10mg;
Triamcinolone Acetonide 1mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
50 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin
125mg/5ml
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
51 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mg Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
52 BRU08060081P Betagen Eye/ Ear Drops Gentamicin Sulphate equivalent to
Gentamicin 0.3%;
Betamethasone Sodium Phosphate
0.1%
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
53 BRU08060082P Muprin Ointment Mupirocin 2.0%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
54 BRU08060083P Eryson Granules 200 Erythromycin ethylsuccinate equiv.
to eryhtromycin 200mg/5ml
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
55 BRU08060084P Eryson Granules 400 Erythromycin ethylsuccinate equiv.
to eryhtromycin 400mg/5ml
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
56 BRU08060085P Neomycin Cream 0.5% Neomycin sulphate 0.5%w/w Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
57 BRU08060086P Foban Hydro Cream Fusidic acid 2%; Hydrocortisone 1% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
58 BRU08060087P Foban Hydro Ointment Sodium Fusidate 2%;
Hydrocortisone 1%
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
59 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
60 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
61 BRU08070090P Zinnat Suspension 125mg/5ml Cefuroxime Axetil equivalent to
Cefuroxime 250mg
Glaxo Wellcome Bernard Castle,
United Kingdom
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
62 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 4 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
63 BRU08070092P Eryson Tablet 250 Erythromycin Stearate BP
equivalent to Eryhthromycin
250mg
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
64 BRU08070094P Ecocort Cream Econazole Nitrate 1% w/w;
Triamcinolone Acetonide 0.1%
w/w
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
65 BRU08070095P Beprogent Ointment Betamethasone 0.05%; Gentamicin
0.1%
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
66 BRU08070096P Betamox Capsule 250mg Amoxicillin Trihydrate equivalent
to Amoxicillin 250mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
67 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
68 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
69 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
70 BRU08070101P Zovirax Suspension
200mg/5ml
Acyclovir 200mg/5ml GlaxoSmithKline GmbH & Co
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
71 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1g GlaxoSmithKline Manufacturing
SPA, Italy
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
72 BRU08080104P Beavate Cream 0.1% Betamethasone -17- valerate
equiv. to Betamethasone 0.1%
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
73 BRU08080106P Candazole Cream Clotrimazole 1.0% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
GSL
74 BRU08080107P Gentamicin Cream Gentamicin (as Sulphate) 0.1% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
75 BRU08080108P Beprogent Cream Betamethasone (as dipropionate)
0.05%, Gentamicin (as sulphate
0.1%)
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
76 BRU08080109P Unasyn Tablet 375mg Sultamicillin (as tosilate) 375mg
(Ampicillin 250mg & Sulbactam
125mg)
Pfizer Global Supply Japan Inc,
Japan
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
77 BRU08080110P Zovirax Dispersable Tablet
200mg
Aciclovir 200mg Glaxo Wellcome, S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
78 BRU08080111P Valtrex® 500mg Tablet Valciclovir (as HCl) 500mg Glaxo Wellcome SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
79 BRU08080112P Fortum® Injection 2g Ceftazidime (as pentahydrate) 2g GlaxoSmithKline Manufacturing
SPA, Italy
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 5 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
80 BRU08080115P Vaxcel Cefuroxime 750mg
Injection
Cefuroxime (as sodium) 750mg Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
81 BRU08080116P Vaxcel Ceftriaxone 1g
Injection
Ceftriaxone (as sodium) 1g Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
82 BRU08080117P Axcel Fusi-Corte Cream Fusidic acid 2%, Betamethasone (as
17-valerate) 0.1%
Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
83 BRU08090118P Verorab Injection Inactivated rabies virus (Wistar
strain RABIES PM/WI 38-1503-3M)
produced on VERO cell line,
inactivated and purifed
Sanofi Pasteur, France; Sanofi
Winthrop Industrie (SWI), Le Trait
– France (Diluent)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
84 BRU08090119P Decocort Cream Miconazole Nitrate 2%w/w;
Hydrocortisone 1% w/w
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
85 BRU08090120P Fobancort Ointment Sodium Fusidate 2%w/w;
Betamethasone 0.05%w/w (as
Dipropionate 0.064%)
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
86 BRU08090121P Candacort Cream Clotrimazole 1.0% w/w;
Hydrocortisone 1.0%w/w
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
87 BRU08090124P Ciprobay® 200 Infusion
Solution
Ciprofloxacin (as lactate) 200mg Bayer AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
88 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as pentahydrate) 2g Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
89 BRU08090126P Axcel Fusidic Cream Fusidic acid 2% w/w Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
90 BRU08090127P Axcel Fusidic Ointment Sodium Fusidate 2%w/w Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
91 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1g Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
92 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/w Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
GSL
93 BRU08090130P Ciprobay 100 Infusion Solution
x 50ml
Ciprofloxacin (as lactate) 100mg Bayer Pharma AG, Leverkeusen,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
P
94 BRU08090131P Beamoxy Capsule 500 Beamoxy Capsule 500 Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
95 BRU08090132P Aroxin Capsule 250mg Amoxicillin (as trihydrate) 250mg Agila Specialties Private Limited,
India; Medreich Limited Unit-1,
Bangalore, India
G & H Trading Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 6 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
96 BRU08090133NPS1;
BRU08090133NPS2
Dhamol Suspension
250mg/5ml
Paracetamol 250mg/5ml Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis
Indonesia, Jakarta Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
GSL (60ml)
97 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
GSL
98 BRU08100135P Betamox Capsule 500mg Amoxicillin Trihydrate equivalent
to Amoxicillin 500mg
Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
99 BRU08100137P Neo Deca Eye/Ear Drop Neomycin Sulphate 0.5%;
Dexamethasone Sodium
Phosphate 0.1% w/w
CCM Pharmaceutical Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
100 BRU08100139P Ciprobay® 500 Tablet Ciprofloxacin (as HCl
monohydrate) 500mg
Bayer Pharma AG, Leverkeusen,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
101 BRU08100140P Avelox Infusion Solution
0.4g/250ml
Moxifloxacin (as Hydrochloride)
400mg
Bayer Pharma AG, Leverkusen,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
102 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride)
400mg
Bayer Pharma AG, Leverkusen,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
103 BRU08100142P Candazole Lotion Clotrimazole 1%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
GSL
104 BRU08100143P Allopurinol 100mg Tablet Allopurinol 100mg Drug Houses of Australia Pte Ltd G & H Trading Company 06 October 2015 till 05
October 2020
POM
105 BRU08100144PS1;
BRU08100144PS2
Bifen Suspension 100mg/5ml Ibuprofen BP 100mg/5ml Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis
Indonesia, Jakarta Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
P
106 BRU08100145NP Dhamol Tablet 500mg Paracetamol BP 500mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
P (1000's)
107 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/w Sunward Pharmaceutical Sdn Bhd
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
P
108 BRU08100147P Difenac 50 Tablet Diclofenac Sodium BP 50mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
109 BRU08100148P Erythro Ethyl Granules Erythromycin (as ethyl succinate)
200mg/5ml
Drug Houses of Australia Pte. Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
110 BRU08110150P Avaxim 160U Suspension for
Injection in a prefilled Syringe
Inactivated Hepatitis A Virus (GBM
strain) 160u/0.5ml
Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
111 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 7 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
112 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mg GlaxoSmithKline Manufacturing
SPA Italy
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
113 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/w Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
114 BRU08110154P Axcel Eryhthromycin ES Tablet
400mg
Erythromycin (as ethyl succinate)
400mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
115 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate)
500mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
116 BRU08110156P Axcel Eryhthromycin ES-200
Suspension
Erythromycin (as Ethylsuccinate)
200mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
117 BRU08110157PS1 ;
BRU08110157PS2
Soden Tablet 275mg Naproxen Sodium BP 275mg Drug House of Australia Pte Ltd,
Singapore ;
PT Actavis Indonesia, Indonesia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
118 BRU08110158NP Dhamol Suspension
120mg/5ml
Paracetamol BP 120mg/5ml Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
GSL (100mL)
119 BRU08110159P Miconazole Cream 2.0%w/w Miconazole Nitrate 2.0%w/w Sunward Pharmaceutical Sdn Bhd
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
GSL
120 BRU08110160P Malarone Tablet Atovaquone 250mg, Proguanil HCl
100mg
GlaxoSmithKline Inc Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
121 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
122 BRU08110163P CoAprovel 150/12.5mg Film-
coated Tablet
Irbesartan 150mg,
Hydrochlorothiazide 12.5mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
123 BRU08110165P;
BRU08110165PS2
Betasone Cream 0.1%w/w Betamethasone (as 17-valerate)
0.1%w/w
Drug Houses of Australia Pte Ltd;
PT Actavis Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
124 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl
monohydrate) 250mg
Bayer Pharma AG, Leverkusen,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
125 BRU08120167P Axcel Cephalexin 250mg
Caspule
Cephalexin (as Monohydrate)
250mg
Kotra Pharma (M) Sdn Bhd
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
126 BRU08120168P Axcel Cephalexin 125mg
Suspension
Cephalexin (as Monohydrate)
125mg
Kotra Pharma (M) Sdn Bhd
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
127 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mg Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
128 BRU08120170P Hydrocrotisone Cream 1%
w/w
Hydrocortisone acetate BP 1%w/w Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
129 BRU08120171P Beamoxy Tablet 250 Amoxicillin (as trihydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 8 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
130 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
131 BRU08120174P;
BRU08120174PS2
Dhacopan Syrup 5mg/5ml Hyoscine (as butylbromide) BP
5mg/5ml
Drug Houses of Australia Pte Ltd,
Singapore; PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
132 BRU08120175P;
BRU08120175PS2
Phenexpect Syrup Per 5ml - Diphenhydramine (as
HCl) 12.5mg, Ammonium Chloride
135mg
Drug Houses of Australia Pte Ltd,
Singapore; PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
133 BRU08120176P Dhabesol Cream 0.05% Clobetasol (as propionate) 0.05%
w/v
Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
134 BRU08120177P Beprosalic Lotion Betamethasone (as dipropionate)
0.05%, Salicylic acid 2.0%
Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
135 BRU08120178PS1;
BRU08120178PS2
Zenmolin Syrup 2mg/5ml Salbutamol (as sulphate) BP
2mg/5ml
Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
136 BRU08120180P Zithromax Film-coated Tablet
250mg
Azithromycin (as dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
137 BRU09010181P Unasyn 0.75mg IM/IV Ampicillin (as sodium) 500mg;
Sulbactam (as sodium) 250mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
138 BRU09010182P Unasyn 3.0g IM/IV Ampicillin (as sodium) 2000mg;
Sulbactam (as sodium) 1000mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
139 BRU09010183P Vaxcel Ceftriaxone-500mg
Injection
Ceftriaxone (as sodium) 500mg Kotra Pharma (M) Sdn Bhd
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
140 BRU09010184PS1;
BRU09010184PS2
Aroxin granules 125mg/5ml Amoxicillin (as trihydrate)
125mg/5ml
Drug Houses of Australia Pte Ltd,
Singapore (S1); Medreich Limited
Unit-1, India (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
141 BRU09010185P Pacofen Tablet Paracetamol 500mg; Codeine
Phosphate 8mg; Caffeine
anhydrous 30mg
Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
142 BRU09010186P Plavix Tablet 75mg Clopidogrel (as Hydrogen Sulphate)
75mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
143 BRU09010187P Symbicort Turbuhaler
160/4.5mcg dose
Budenoside 160mcg; Formoterol
fumarate dihydrate 4.5mcg
AstraZeneca AB, Sodertalje,
Sweden
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 9 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
144 BRU09010188P CoAprovel 300/12.5mg film-
coated tablet
Irbesartan 300mg;
Hydrochlorothiazide 12.5mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
145 BRU09010189PS1;
BRU09010189PS2
Vasican Syrup 4mg/5ml Bromhexine HCl BP 4mg/5ml Drug House of Australia Pte Ltd,
Singapore (S1); PT Actavis
Indonesia, Jakarta
Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
146 BRU09010190P Cardium 30 tablet Diltiazem HCl 30mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
147 BRU09010191PS1 &
BRU09010191PS2
Coversyl 8mg tablet Perindopril tert-butylamine 8mg Les Laboratoires Servier Industrie,
France (S1) & Kotra Pharma (M)
Sdn. Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
148 BRU09010194P Pulmicort turbuhaler
100mcg/dose
Budenoside 100mcg AstraZeneca AB, Sodertalje,
Sweden
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
149 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/ml Sanofi Aventis Deutschland,
Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
150 BRU09020196P Zovirax Cream 5% Aciclovir 5%w/w Glaxo Wellcome Opertions, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
151 BRU09020197P Zovirax Eye Ointment 3% Aciclovir 3%w/w Jubilant HollisterStier General
Partnership, Canada
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
152 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2ml Famar Health Care Services
Madrid S.A.U., Madrid, Spain
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
153 BRU09020201NPS1,
BRU09020201NPS2
Dhamol Suspension
500mg/5ml
Paracetamol BP 500mg/5ml Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
P (3.8L)
154 BRU09020204P Beamoxy Tablet 500 Amoxicillin (as trihydrate 575mg)
500mg
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
155 BRU09020205PS1 &
BRU09020205PS2
Fedac Syrup Pseudoephedrine 30mg/5ml;
Triprolidine 1.25mg/5ml
Drug House of Australia Pte Ltd,
Singapore (S1); PT Actavis
Indonesia, Jakarta
Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
156 BRU09020206P Bricanyl Turbuhaler
0.5mg/dose
Terbutaline Sulphate 0.5mg/dose AstraZeneca AB, Sodertalje,
Sweden
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 10 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
157 BRU09020207P Beprosalic Ointment Betamethasone (as Dipropionate
0.064%) 0.05% & Salicylic acid 3%
w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
158 BRU09020208P Beprogel Topical Solution Betamethasone (as Dipropionate
0.064%) 0.05% w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
159 BRU09020209P Cloderm Scalp Application Clobetasol (as dipropionate) 0.05%
w/v
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
160 BRU09020210P Declovir Cream Acyclovir 5.0% w/w HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
161 BRU09020211P Lantus 100units/ml for Optiset Insulin Glargine (HOE 901)
100units/ml
Sanofi-Aventis Deutschland
GmbH, Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
162 BRU09020212P Glucobay 50 Tablet Acarbose 50mg Bayer Pharma AG, Leverkusen,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
163 BRU09030213P 3TC Tablet 150mg Lamivudine 150mg GlaxoSmithKline Pharmaceuticals
S.A., Poland
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
164 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
165 BRU09030215P Dhatrin Tablet Sulphamethoxazole BP 400mg;
Trimethoprim BP 80mg
Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
166 BRU09030216P Cordarone Injection
150mg/3ml
Amiodarone 150mg/3ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
167 BRU09030217PS1 &
BRU09030217PS2
Vastarel MR 35mg Tablet Trimetazidine HCl 35mg Les Laboratoires Servier Industrie,
France (S1); Kotra Pharma (M)
Sdn. Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
168 BRU09030218P0.5gS
&
BRU09030218P0.5gA
Tetavax Suspension for
Injection (Single dose 0.5ml)
Purified Tetanus Toxoid Sanofi Pasteur, Marcy L'Etoile,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
169 BRU09030219P Cataflam 1.5% Oral Drops
Suspension
Diclofenac Sodium 15mg/ml Novartis Farma SpA, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 11 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
170 BRU09030220P Vaxigrip Influenza Vaccine
SH2017:
Split influenza virus*, inactivated
containing antigens equivalent to
the following strains per one 0.5ml
dose:
• A/Michigan/45/2015 (H1N1)
pdm09-like strain (A
A/Michigan/45/2015, NYMC X-275
…..…………15 mcg HA**
• A/Hong Kong/4801/2014 (H3N2)-
like strain (A/Hong
Kong/4801/2014, NYMC X-
263B)…………..…...15 mcg HA**
• B/Brisbane/60/2008-like strain
(B/Brisbane/60/2008, wild
type)……………………………………………
…….15 mcg HA**
Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
171 BRU09030221P Lignocaine HCl BP Injection 1%
(5ml)
Lidocaine HCl (Lignocaine HCl) 1%
(50mg/5ml)
Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
172 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto
Rico
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
173 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto
Rico
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
174 BRU09030224P Beprosone Ointment Betamethasone (as Dipropionate
0.064%) 0.05% w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
175 BRU09030225P Beprosone Cream Betamethasone (as Dipropionate
0.064%) 0.05% w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
176 BRU09030226P Benosone-N Cream Betamethasone (as Valerate
0.12%) 0.1% w/w; Neomycin
Sulphate 0.5%w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 12 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
177 BRU09030227P Pocin H Ear Drop Neomycin Sulphate B.P. 3,400 i.u.;
Polymyxin B Sulphate B.P.10,000
i.u; Hydrocortisone B.P.10mg
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
178 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/w HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
179 BRU09040229P Unasyn Powder for Oral
Suspension 250mg/5ml
Sultamicillin (as tosilate) 250mg Pfizer Global Supply Japan, Inc.,
Japan
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
180 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
181 BRU09040231P Knowful Capsule 400mg Piracetam 400mg YSP Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
182 BRU09040232P0.5gV
&
BRU09040232P0.5gS
Stamaril Vaccine Live attenuated Yellow Fever Virus
17 D-204 strain (per 0.5ml - Not
less than 1000 LD50 units of the
virus)
Sanofi Pasteur, Campus Merieux &
Sanofi Pasteur, Parc industriel
d’Incarville, France; Sanofi
Winthrop Industrie (SWI), Le Trait
– France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
183 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
184 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride)
150mg
YSP Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
185 BRU09040235P Voltaren 75mg/3ml solution
for injection
Diclofenac Sodium 75mg/3ml Novartis Pharma Stein, ag,
Switzerland; Lek Pharmaceuticals
d.d, Slovenia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
186 BRU09040237P Depo-Medrol Sterile Aqueous
Suspension 40mg/ml (5ml)
Methylprednisolone Acetate
200mg/5ml
Pfizer Manufacturing Belgium NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
187 BRU09040238P Typhim Vi Vaccine (20 doses) Per 0.5ml - Purified Vi Capsular
Polysaccharide of Salmonella typhi
(Ty2 strain)
Sanofi Pasteur, Campus Merieux &
Sanofi Pasteur, Parc Insutrial
d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
188 BRU09040239P Bupivacaine Hydrochloride BP
0.5% w/v injection
Bupivacaine hydrochloride BP
0.5%w/v
Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
189 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mg Pfizer Pharmaceutical LLC, Vega
Baja Puerto Rico
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
190 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SpA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 13 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
191 BRU09040243P T3 Mycin Gel Clindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
192 BRU09040244P Cloderm Cream Clobetasone (as butyrate)
0.05%w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
193 BRU09040245P Bisacodyl Suppositories Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
P
194 BRU09040246P U-Closone Ointment Clobetasol (as propionate)
0.05%w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
195 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
196 BRU09050248NPS1;
BRU09050248NPS2
Dhactulose Syrup Lactulose 67%w/w Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
GSL (200mL) &
P(1L)
197 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride
20mg
Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
198 BRU09050250P Coversyl Plus Tablet Perindopril tert-butylamine 4mg,
Indapamide 1.25mg
Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
199 BRU09050251P Methyldopa Tablet 250mg Methyldopa (as anhydrous) 250mg Drug House of Australia (Asia) Pte
Ltd, Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
200 BRU09050252P Glucobay Tablet 100mg Acarbose 100mg Bayer Pharma AG, Leverkusen,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
201 BRU09050253P Benosone-N Ointment Betamethasone (as valerate 0.12%
w/w) 0.1% w/w, Neomycin
Sulphate 0.50%w/w
HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
202 BRU09050254P Benosone Ointment Betamethasone 0.1% w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
203 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
204 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0%
w/v
HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
205 BRU09050258P Lobesol Cream Clobetasol (as propionate)
0.05%w/w
Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
206 BRU09060259P Vaxcel Cefuroxime 1.5g
Injection
Cefuroxime (as sodium) 1.5g Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 14 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
207 BRU09060260P Tetavax Suspension for
Injection (multidose)
(1 vial of 5mL – 10 doses)
Tetanus toxoid 40i.u/0.5ml dose Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
208 BRU09060261P Beamoxy Capsule 250 Amoxycillin (as trihydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn
Bhd
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
209 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Saglik, Gida ve Tarim
Urunleri San. Ve Tic. A.S. Yenisehir
Mahalledi, Turkey
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
210 BRU09060264P Voltaren 12.5mg
Suppositories
Diclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
211 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
212 BRU09060266P Benosone Cream Betamethasone (as valerate)
0.1%w/w
HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
213 BRU09060268P Betamethasone Cream Betamethasone (as valerate)
0.1%w/w
Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
214 BRU09060269P Zorax Cream Aciclovir 5%w/w Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
215 BRU09060270P Nexium mups 20mg Esomeprazole (as magnesium
trihydrate) 20mg
AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
216 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mg Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
217 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mg Pfizer Pharmaceuticals LLC, Vega
Baja Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
218 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mg GlaxoSmithKline Australia Pty Ltd,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
219 BRU09070275P Unasyn IM/IV 1.5g Sulbactam (as sodium 546.4mg)
500mg & Ampicillin (as sodium
1084.6mg) 1000mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
220 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM
strain) 80u per 0.5ml
Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
221 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mg Recipharm Uppsala AB, Bjorkgatan
30, SE-751 82 Uppsala, Sweden.
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
222 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg Aspen Port Elizabeth (Pty) Ltd,
Republic of South Africa
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 15 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
223 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia.
G & H Trading Company 06 October 2015 till 05
October 2020
POM
224 BRU09070282P Hydrocortisone Cream 1%
w/w
Hydrocortisone acetate 1%w/w Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
225 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
226 BRU09070284P Nexium mups 40mg Esomeprazole (as magnesium
trihydrate) 40mg
AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
227 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
228 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
229 BRU09070288P Diane-35 Tablet Cyproterone acetate 2mg;
Ethinylestradiol 0.035mg
Bayer Weimar GmbH und Co. KG,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
230 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
231 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., Italy Hongkiat Trading & Company 06 October 2015 till 05
October 2020
P
232 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/w Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
233 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mg PT Boehringer Ingelheim
Indonesia, Bogor, Indonesia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
234 BRU09080295P Pulmicort® Turbuhaler®
200mcg/dose
Budesonide (micronised) Ph Eur
200mcg/dose
AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
235 BRU09080296P Epilim Intravenous 400mg/
vial
Sodium Valproate 400mg Gruppo Lepetit S.R.L. Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
236 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
237 BRU09080299P Beafemic Suspension
50mg/5ml
Mefenamic acid 50mg/5mL Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
238 BRU09080300PS1 &
BRU09080300PS2
Diamicron MR Tablet 30mg Gliclazide 30mg Les Laboratoires Servier Industrie,
France (S1) & Kotra Pharma (M)
Sdn. Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
239 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
240 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 16 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
241 BRU09080303P Spiriva® 18mcg Tiotropium 18mcg (as Bromide
Monohydrate 22.5mcg)
Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
242 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
243 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd,
Malaysia
Asterix United Sdn Bhd 06 October 2015 till 05
October 2020
P (10 x 10's)
244 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromide Delpharm Reims S.A.S,France Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
245 BRU09080308P Atrovent N 20µg/ puff
Metered Dose Inhaler
Ipratropium bromide anyhdrous
20mcg (as monohydrate 21mcg)
Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
246 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
247 BRU09080311P Carinox Capsule Pseudoephedrine sulphate 120mg;
Loratadine 5mg
Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
248 BRU09090313P Typhim Vi Single Dose Purified Vi Capsular
polysaccharides of Salmonella
typhi (Ty2 strain) 25µg/0.5ml
Sanofi Pasteur, Campus Merieux,
France & Sanofi Pasteur, Parc
industrial d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
249 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
250 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mg Novartis Farma S.p.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
251 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mg Novartis Saglik, Gida ve Tarim
Urunleri San. Ve Tic. A.S. Yenisehir
Mahalledi, Turkey
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
252 BRU09090322P Actilyse® Treatment-Set Recombinant Human Tissue-type
Plasminogen Activator (alteplase)
50mg
Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
253 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
254 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
P (100x10's)
255 BRU09090327P Metalyse Injection
10,000units
Tenecteplase 10,000units (50mg) Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
256 BRU09090328NP Hemo RidTM Tablet Miconised Diosmin 450mg;
Micronised Hesperidine 50mg
Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
257 BRU09090329P Exforge Tablet 5mg/80mg Amlodipine 5mg (as besylate
6.94mg); Valsartan 80mg
Novartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 17 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
258 BRU09100330P Imovax Polio Vaccine Inactivated Polio Virus: Type 1
(40DU/0.5mL), Type 2
(80DU/0.5mL), Type 3
32DU/0.5mL)
Sanofi Pasteur, Lyon, France ;
Sanofi Winthrop Industrie, Le Trait
(France)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
259 BRU09100331P Cloderm Ointment Clobetasol (as propionate)
0.05%w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
260 BRU09100332P H-Cort Cream Hydrocortisone 1%w/w HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
261 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical Sdn Bhd,
Malaysia.
G & H Trading Company 06 October 2015 till 05
October 2020
POM
262 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5ml GlaxoSmithKline Australia Pty Ltd,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
263 BRU09100336NP Sunquadin Lozenges Dequalinium Chloride Sunward Pharmaceutical Sdn Bhd,
Malaysia.
G & H Trading Company 06 October 2015 till 05
October 2020
POM
264 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg Pfizer Manufacturing Deutschland
GmbH, Germany
(Manufacturing, packaging, testing
and release.
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
265 BRU09100338NP Uphamol 250 Suspension
(Fruity)
Paracetamol 250mg/5mL Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL (60mL and
100mL)266 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV Industriezone, Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
267 BRU09100340P Pontalon Capsule Mefenamic acid 250mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
268 BRU09100342NP Maalox Plus Tablet Aluminium hydroxide dried gel
200mg, Magnesium hydroxide
200mg, Simethicone 26.25mg
(correspond to 25mg of
polydiemthylsiloxane)
Sanofi-Aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
GSL
269 BRU09100343P Neurontin 600mg Tablet Gabapentin 600mg Pfizer Pharmaceutical LLC, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
270 BRU09100345P LipitorTM 40mg Tablet Atorvastatin (as Calcium 43.38mg-
crystalline) 40mg
Pfizer pharmaceuticals LLC, vega
baja Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
271 BRU09100346NP Suniton Tablet Paracetamol 450mg, Orphenadrine
Citrate 35mg
Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
272 BRU09100347P SCMC Plus Syrup 250mg/5mL S-carboxy-methylcysteine
250mg/5mL (Carbocisteine)
Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 18 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
273 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
274 BRU09100349P Actonel® 35mg Tablet Risedronate sodium 35mg
(equivalent to 32.5mg risedronic
acid)
Norwich Pharmaceuticals Inc., USA G&H Trading Company 06 October 2015 till 05
October 2020
POM
275 BRU09110350P Lantus® Solostar® 100units/ml Insulin Glargine (HOE 901) Sanofi-Aventis Deutschland
GmbH, Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
276 BRU09110353P Tenoretic Tablet Atenolol 100mg; Chlorthalidone
25mg
AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
277 BRU09110354P LipitorTM 10mg Tablet Atorvastatin (as calcium 10.85mg -
crystalline) 10mg
Pfizer pharmaceutical LLC, vega
baja Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
278 BRU09110357P Atrovent Unit Dose Vial (UDV)
250mcg/2ml
Ipratropium bromide anhydrous
250mcg (as monohydrate 261mcg)
Laboratoire Unither, France (S2) Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
279 BRU09110359P Allavin Expectorant Diphenhydramine HCl 14mg/5ml;
Ammonium Chloride 135mg/5ml
Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
280 BRU09110361NP Uphamol 500 Tablet Paracetamol 500mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
P (100 x 10's)
281 BRU09110362P Carin Tablet 10mg Loratadine 10mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
P
282 BRU09110363P Rhinathiol 2% for Children
Syrup
Carbocisteine 100mg/5ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
283 BRU09120365P Tienam IV Injection 500mg Imipenem (as monohydrate)
500mg & Cilastatin Sodium 500mg
Merck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
284 BRU09120366PS1 &
BRU09120366PS2
Opvero (Oral trivalent
poliomyelitis vaccine)
Each 0.1mL (2 drops) contains:
Type1 poliomyelitis virus (LS-c2ab
strain) ≥ 106.0 CCID50; Type2
poliomyelitis virus (p712,Ch,2ab
strain) ≥ 105.0 CCID50; Type3
poliomyelitis virus (Leon 12a1b
strain) ≥ 105.8 CCID50;
Sanofi Pasteur, Campus Merieux,
France (S1); Sanofi Pasteur, Parc
industrial d'Incarville, France (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
285 BRU09120367P Dilantin 100mg Capsule Phenytoin Sodium Pfizer Pharmaceuticals LLC, Vega
Baja, USA (Pfizer Vega Baja)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 19 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
286 BRU09120369P Oral Aid Lotion Lignocaine HCl 2.5%;
Triamcinolone Acetonide 0.1%;
Chlorhexidine HCl 0.5%
Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
287 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
288 BRU09120376NP Poro Suppository 125mg Paracetamol 125mg Y.S.P Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
GSL (1 x 5's); P(10
x 10's)289 BRU09120377P Vascor 40mg Film-coated
Tablet
Simvastatin 40mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
290 BRU09120378P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
P
291 BRU09120379P Covastin Film-coated Tablet
10mg
Simvastatin 10mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
292 BRU09120380P Metformin Tablet 500 Metformin HCl 500mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
293 BRU09120381PS2 Co-Diovan 80/12.5 Film-
coated Tablets
Valsartan 80mg;
Hydrochlorothiazide 12.5mg
Novartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
294 BRU09120382P Rhinathiol® Promethazine
syrup
Carbocisteine 100mg/5ml;
Promethazine HCl 2.5mg/5ml
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
295 BRU09120383P Methotrexate Injection BP
1000mg/10ml
Methotrexate 1000mg/10ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
296 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mg Aspen Port Elizabeth (Pty) Ltd,
Republic of South Africa
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
297 BRU10010385PS1 &
BRU10010385PS2
Coversyl 4mg Tablet Perindopril tert-butylamine 4mg Les Laboratoires Servier Industrie,
France (S1) & Kotra Pharma (M)
Sdn Bhd., Malaysia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
298 BRU10010386PS2 Atrovent Unit Dose Vial
0.5mg/2ml
Ipratropium bromide (as
monohydrate) 500mcg/2ml
Laboratoires Unither, Amiens
cedex, France (S2)
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
299 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
300 BRU10010388P Exforge Tablet 5mg/160mg Amlodipine 5mg (as besylate
6.94mg); Valsartan 160mg
Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
301 BRU10010390NPS3 Dulcolax 5mg Tablet Bisacodyl 5mg Delpharm Reims S.A.S., France
(S3)
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
P
302 BRU10010391PS2 Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 20 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
303 BRU10010392PS2 Co-Diovan 160/25 Film-coated
Tablets
Valsartan 160mg;
Hydrochlorothiazide 25mg
Novartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
304 BRU10010393P Chloramine 4 Syrup Chlorpheniramine maleate BP
4mg/5ml
Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
P
305 BRU10010395P Isoket Spray Isosrobide Dinitrate 1.25mg per
actuation
Schwarz Pharma Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
306 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
307 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
308 BRU10010399P Seretide Accuhaler 50/500 Salmeterol 50mcg (as Xinafoate),
Fluticasone propionate 500mcg
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
309 BRU10020402P Solu-Medrol Sterile Powder
500mg
Methyprednisolone (as Sodium
succinate) 500mg
Pfizer Manufacturing Belgium
N.V., Belgium
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
310 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
311 BRU10020405P Vascor Tablet 20mg Simvastatin Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
312 BRU10020406P
Combivent Unit Dose Vials
Nebuliser Solution
Per 2.5ml - Ipratropium bromide
(as monohydrate 522mcg) 500mcg;
Salbutamol 2.5mg (as sulphate
3.013mg)
Laboratorie UNITHER , France Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
313 BRU10020407P Perinace Tablet 4mg Perindopril erbumine 4mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
314 BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
315 BRU10020410P Etoposide 100mg/5ml
Injection
Etoposide 100mg/5ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
316 BRU10020411P Decondine Syrup Per 5ml - Triprolidine HCl 1.25mg;
Pseudoephedrine HCl 30mg
Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
317 BRU10020412P Seretide Accuhaler 50/100 Salmeterol 50mcg (as Xinafoate),
Fluticasone propionate 100mcg
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
318 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/w Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
319 BRU10020414P Sunadine Syrup Loratadine 5mg/5ml Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
P
BDMCA/RMP/0319 Page 21 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
320 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
321 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mg Pfizer Pharmaceutical LLC, Puerto
Rico
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
322 BRU10020418P Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin
25mg
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
323 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
324 BRU10030423P Rhinathiol 5% Adult
Expectorant Syrup
Carbocisteine 5g/100ml Unither Liquid Manufacturing,
France
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
P
325 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mg Instituto De Angeli S.R.L., Italy Hongkiat Trading & Company 06 October 2015 till 05
October 2020
P
326 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
327 BRU10030427P Omesec Capsule 20mg Omeprazole 20mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn Bhd 06 October 2015 till 05
October 2020
POM
328 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
329 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mg Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
330 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
331 BRU10030432P Cisplatin CS Injection
50mg/50ml
Cisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
332 BRU10030433P Terramycin Ophthalmic
Ointment
Per g - Oxytetracycline 5mg;
Polymyxin B 10,000units
PT Pfizer (Indonesia), Indonesia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
333 BRU10030435P Adriamycin CS Injection
50mg/25ml
Doxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
334 BRU10030436NP Maalox® Plus Suspension Per 5ml - Aluminium hydroxide
225mg; Magnesium hydroxide
200mg; Simethicone USP 25mg
A. Nattermann & Cie GmbH,
Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
GSL
335 BRU10030437P Seretide Evohaler 50 Salmeterol Xinafoate (micronised)
25mcg; Fluticasone Propionate
(micronised) 50mcg
Glaxo Wellcome Production,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
336 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HCl Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
337 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mg Daiichi Sankyo Europe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 22 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
338 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
339 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
340 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
341 BRU10040444NP Cartril-S 500mg Capsule Glucosamine HCl 472.5mg
equivalent to Glucosamine content
in Glucosamine Sulphate 500mg
Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
GSL
342 BRU10040445P Seretide Accuhaler 50/250 Salmeterol (as Xinafoate) 50mcg;
Fluticasone Propionate 250mcg
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
343 BRU10040450P Seretide 125 Evohaler Salmeterol (as Xinafoate,
micronised) 25mcg; Fluticasone
Propionate 125mcg
Glaxo Wellcome Production,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
344 BRU10040452P Nitroderm TTS® 10 Glyceral trinitrate/ nitroglycerin
50mg (10mg/24hr)
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
345 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
346 BRU10040454NP ColimixTM Syrup Per 5ml - Simethicone (activated
dimethicone) 50mg; dicylcomine
HCl 5mg
Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
347 BRU10040455P Xepanicol® Eye Drops 0.5% Chloramphenicol 0.5% Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
348 BRU10040457P S2 Co-Diovan 160/12.5mg
Tablets
Valsartan HCl 160mg;
Hydrochlorothiazide 12.5mg
Novartis Pharma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
349 BRU10040459P Atenolol 50mg Tablet Atenolol 50mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
350 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
351 BRU10040461P Cytarabine® Injection 1000mg
in 10ml
Cytarabine 1000mg/10ml Pfizer (Perth) Pty, Ltd., Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
352 BRU10040462P Exelon Oral Solution 2mg/ml Rivastigmine 2mg/ml (as hydrogen
tartrate)
Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 23 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
353 BRU10050463P Nebido 1000mg/4ml, Solution
for Injection
Testosterone undecanoate
250mg(equiv. to testosterone
157.9mg)
Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
354 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride
30mg/5ml
Delpharm Reims S.A.S., France Hongkiat Trading & Company 06 October 2015 till 05
October 2020
P
355 BRU10050466NP Uphamol Suspension 250
(Orange)
Paracetamol 250mg/5ml Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL (60mL); P
(3.8L)356 BRU10050468P Remicade Powder for
Concentrate for Solution for
Infusion 100mg/vial
Infliximab (cA2 IgG) 100mg/vial Patheon Italia S.p.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
357 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/w Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
358 BRU10050471P Zyvox Infusion Bag
600mg/300ml
Linezolid 600mg/300ml Fresenius Kabi Norge As, Norway Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
359 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mg Ono Pharmaceutical Co Ltd, Japan Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
360 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
361 BRU10050475P Zyrtec® Oral Solution 1mg/ml Cetrizine diHCl 1mg/ml (0.1%) Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM P
362 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride)
150mg
Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
363 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mg Novartis Saglik Gida ve Tarim
Urunleri San. Ve Tic.A.S., Istanbul,
Turkey
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
364 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
365 BRU10050479P Cozaar 100mg film-coated
tablet
Losartan Potassium 100mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
366 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate)
10mg/Ml
Zoetis LLC, Kalamazoo, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
367 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
P
368 BRU10060487P Asmol Syrup Salbutamol 2mg/5ml (as Sulphate
2.4mg)
Sunward Pharmaceutical Sdn.
Bhd., Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
369 BRU10060489P Lescol XL Tablet 80mg Fluvastatin (as the sodium salt)
80mg
Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
370 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mg Sunward Pharmaceutical Sdn.
Bhd., Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 24 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
371 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mg Novartis Saglik Gida ve Tarim
Urunleri San. Ve Tic.A.S., Istanbul,
Turkey
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
372 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mg Daiichi Sankyo Europe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
373 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mg Pfizer Australia Pty. Ltd., NSW
Australia.
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
374 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing,
France.
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
375 BRU10060496P Stilnox 10mg film-coated
tablet
Zolpidem tartrate 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
376 BRU10060497P Hyosun syrup Hyoscine-N-Butylbromide
(Scopolamine Butylbromide)
5mg/5ml
Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
377 BRU10060498P Nalol Tablet 40mg Propranolol HCl 40mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
378 BRU10060499P Exelon capsule 1.5mg Rivastigmine 1.5mg (as hydrogen
tartrate 2.4mg)
Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
379 BRU10060500P Syntocinon 10IU solution for
injection
Synthetic Oxytocin 10IU/ml Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
380 BRU10060501P Exelon capsule 6mg Rivastigmine 6mg (as hydrogen
tartrate 9.6mg)
Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
381 BRU10060502P Zyvox film-coated tablet
600mg
Linezolid 600mg Pfizer Pharmaceuticals LLC, Puerto
Rico, United States
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
382 BRU10060504P Sifrol tablet 0.125mg Pramipexole 0.088mg (eqv. to
Pramipexole dihydrochloride
monohydrate 0.125mg)
Boehringer Ingelheim Pharma
GmbH & Co. Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
383 BRU10060505P Myfortic Gastro-Resistant
tablet 180mg
Mycophenolic Acid 180mg (as
Sodium Salt 192.4mg)
Novartis Pharma Produktions
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
384 BRU10070506P Phensedyl Dry Cough Linctus Per 5ml - Promethazine HCl 3.6mg;
Pholcodine 4mg; Ephedrine HCl
7.2mg
Sanofi-Aventis Pakistan Limited,
Pakistan
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
385 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mg Pfizer Australia Pty. Ltd., NSW
Australia.
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
386 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
P
387 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
GSL (6's) & P
(60's)
BDMCA/RMP/0319 Page 25 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
388 BRU10070511P Decondine Tablet Tripolidine HCl 2.5mg;
Pseudoephedrine HCl 60mg
Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
389 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
390 BRU10070513P;
BRU10070513PS2
Desferal 500mg Desferrioxamine Methane
Sulphonate
Novartis Pharma Stein AG,
Switzerland; Wasserburger
Arzneimittelwerk GmbH,
Wasserburg
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
391 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
392 BRU10070515P Zaricort Cream Miconazole Nitrate 2%w/w;
Hydrocortisone 1%w/w
Xepa-Soul Pattinson (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
393 BRU10070516P Singulair® Tablet 10mg Montelukast (as sodium) 10mg Merck Sharp & Dohme Ltd.,
United Kingdom
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
394 BRU10070517P Singulair® Chewable Tablet
5mg
Montelukast (as sodium) 5mg Merck Sharp & Dohme Ltd.,
United Kingdom
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
395 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2ml GlaxoSmithKline Manufacturing
SpA., Italy
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
396 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate)
500mg
Pharmacia & Upjohn Company,
Kalamazoo, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
397 BRU10070520P Exelon® 4.5mg Capsule Rivastigmine 4.5mg (as
Rivastigmine hydrogen tartrate
7.2mg)
Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
398 BRU10070521P Epilim Chrono 500mg Scored
Film-coated Tablet
Sodium valproate 500mg (Sodium
valproate 333mg & Valproic acid
145mg)
Sanofi Winthrop Industries, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
399 BRU10070522P Ritalin® Modified Release
Capsule 30mg
Methylphenidate HCl 30mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
400 BRU10080523P Exforge 10/160mg FC Tablet Amlodipine 10mg (as besylate);
Valsartan 160mg
Novartis Farmaceutica SA, Barbera
del Valles
(Barcelona) Spain
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
401 BRU10080524P Zometa Concentrate for
Solution for Infusion 4mg/5ml
Zoledronic Acid (anhydrous) 4mg
corresponding to zoledronic acid
monohydrate 4.264mg
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
402 BRU10080529P Nasacort Aqueous Nasal Spary Triamcinolone Acetonide
55mcg/actuation
Aventis Pharma UK Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 26 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
403 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride
10mg
Novartis Pharmaceuticals SA Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
404 BRU10080531P Proctosedyl Suppositories Chinchocaine 5mg; Framycetin
sulphate 10mg; Hydrocortisone
5mg; Aesculin 10mg
PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
405 BRU10080532P Prostin VR Paediatric® Sterile
Solution 500mcg
Alprostadil 500mcg/ml Pharmacia & Upjohn Company,
USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
406 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
407 BRU10080534PS1;
BRU10080534PS2
Fosamax 70mg Tablet Alendronate sodium 91.37 (as
trihydrate) equivalent to
alendronic acid 70mg
Merck Sharp & Dohme (Italia) SpA,
Italy (S1); Aesica Pharmaceuticals
GmbH, Germany (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
408 BRU10080535PS2 Telfast-D Extended Release
Tablet
Fexofenadine hydrochloride 60mg ;
Pseudoephedrine HCl 120mg
Sanofi Winthrop Industrie, France
(S2)
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
409 BRU10090539P Singulair Tablet 4mg Montelukast 4mg (as sodium
4.16mg)
Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
410 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
411 BRU10090541P Lanoxin Paediatric/ Geriatric
Elixir
Digoxin 0.05mg/mL Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
412 BRU10090542PS1;
BRU10090542PS2
Singulair Oral Granules 4mg Montelukast Sodium (free acid
equivalent) 4mg
Merck Sharp & Dohme Corp. USA
(S1); DSM Pharmaceuticals, Inc.,
USA (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
413 BRU10090543P Frisium® 10mg Tablet Clobazam 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
414 BRU10090544PS2 Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mg MSD International GmbH
(Singapore Branch), Singapore (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
415 BRU10090545P Zocor 10mg Tablet Simvastatin 10mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
416 BRU10090546P Zocor 40mg Tablet Simvastatin 40mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
417 BRU10090548P Suprefact® 1mg/ml Injection
Solution
Buserelin 1.00mg/ml (as acetate
1.05mg)
Aventis-Pharma Deutshland
GmbH, Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
418 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0319 Page 27 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
419 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride
20mg
Recro Gainsville LLC, USA. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
420 BRU10090551P Zoladex LA Depot Injection
10.8mg
Goserelin Acetate equivalent to
Goserelin 10.8mg
AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
421 BRU10090552P Harnal OCAS 400mcg Film-
coated tablet
Tamsulosin (as hydrochloride
400mcg) 367mcg
Astellas Pharma Europe BV, The
Netherlands
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
422 BRU10090554P Proscar® Tablets 5mg Finasteride 5mg MSD International GmbH (Puerto
Rico Branch) LLC., Puerto Rico,
USA.
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
423 BRU10090555PS1;
BRU10090555PS2
Elomet Cream 0.1% Mometasone Furoate 0.1% Schering-Plough Labo N.V.,
Belgium (S1); Schering-Plough
Labo N.V., Belgium (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
424 BRU10100556P Myfortic Gastro-Resistant
tablet 360mg
Mycophenolic (as sodium) acid
360mg
Novartis Pharma Produktions
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
425 BRU10100559P Exelon® Capsule 3mg Rivastigmine (as hydrogen tartrate)
3mg
Novartis Farmaceutica S.A. Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
426 BRU10100560PS2 Arcoxia 60mg Film-coated
tablet
Etoricoxib 60mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
427 BRU10100561P Proctosedyl Ointment Cinchocaine hydrochloride 0.5%;
Framycetin sulphate 1.0%;
Hydrocortisone 0.5%; Aesculin
1.0%
Patheon UK Ltd., England Medipharm Sdn Bhd 28 October 2015 till 27
October 2020
POM
428 BRU10100562P Exelon® Patch 10 Rivastigmine Base 18mg / 10cm2
(9.5mg/24h)
LTS Lohmann Theraphie-System
AG, Germany
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
429 BRU10100563P Exelon® Patch 5 Rivastigmine base 9mg/5cm2
(4.6mg/24 hours)
LTS Lohmann Theraphie-System
AG, Germany
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
430 BRU10100564P ATGAM® Sterile Solution
50mg/mL (5mL amp)
Lymphocyte immune globulin, anti-
thymocyte globulin (equine)
250mg/5mL
Pharmacia & Upjohn Company,
USA
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
431 BRU10100565PS1;
BRU10100565PS2
Ezetrol 10mg Tablet Ezetimibe 10mg 1) MSD International GmbH
(Puerto Rico Branch) LLC, Puerto
Rico (S1); 2) MSD International
GmbH (Singapore Branch),
Singapore (S2)
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
432 BRU10100566PS2 Arcoxia 120mg Tablet Etoricoxib 120mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
433 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Traidng Company 28 October 2015 till 27
October 2020
POM
BDMCA/RMP/0319 Page 28 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
434 BRU10100568P Zithromax Powder For Oral
Suspension 200mg/5ml
Azithromycin (as dihydrate)
200mg/5ml
Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
435 BRU10100569P Fosamax Plus 70/2800mcg
Tablets
Alendronic (as sodium 91.37) acid
70mg & (Vitamin D3 100,000 IU/g)
Cholecalciferol 2800mcg
MSD Frosst Iberica, Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
436 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals USA Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
437 BRU10100572P Casprin Enteric
Microencapsulated Capsule
100mg
Aspirin 100mg Y.S.P. Industries (M) Sdn Bhd,
Malaysia.
Asterix United (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
438 BRU10100573P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P. Industries (M) Sdn Bhd,
Malaysia.
Asterix United (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
439 BRU10100576P Albutein® Solution for Infusion
25%
Albumin (Human) 25% Grifols Biologicals Inc., USA Hongkiat Trading & Company 28 October 2015 till 27
October 2020
POM
440 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mg MSD International GmbH (Puerto
Rico Branch) LLC., Puerto Rico,
USA.
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
441 BRU10100578P Axol Liquid 3mg/ml Ambroxol Hydrochloride 3mg/ml Y.S.P. Industries (M) Sdn Bhd,
Malaysia.
Asterix United (B) Sdn Bhd 28 October 2015 till 27
October 2020
P (100ml) & POM
(4L)442 BRU10100579PS2 Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mg MSD International GmbH
(Singapore Branch), Singapore (S2)
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
443 BRU10110581PS1;
BRU10110581PS2JanuviaTM Tablet 50mg Sitagliptin (as phosphate) 50mg Merck Sharp & Dohme (Italia)
S.p.A., Pavia, Italy (S1); Merck
Sharp & Dohme Ltd, England (S2)
Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
444 BRU10110582PS2 Arcoxia® 90mg Tablet Etrocoxib 90mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
445 BRU10110584P Zocor 20mg Film-coated
Tablet
Simvastatin 20mg Merck Sharp & Dohme Ltd.,
Northumberland, UK
Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
446 BRU10110585P Sifrol® Tablet 1mg Pramipexole dihydrochloride
monohydrate 1mg (equivalent to
0.7mg pramipexole)
Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 24 November 2015 till 23
November 2020
POM
447 BRU10110587P Metoclopramide Syrup
5mg/5ml
Metoclopramide hydrochloride
5mg/5ml
Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Traidng Company 24 November 2015 till 23
November 2020
POM
448 BRU10110588NP Suntacid Tablet Aluminium Hydroxide 250mg,
Magnesium Trisilicate 250mg,
Simethicone 30mg
Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Traidng Company 24 November 2015 till 23
November 2020
GSL
BDMCA/RMP/0319 Page 29 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
449 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
450 BRU10110591P Voren Enteric Coated Tablet
25mg
Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
451 BRU10110592P Oroxine Tablet 50mcg Levothyroxine Sodium 55.63mcg Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
452 BRU10110593P Voren Enteric Coated Tablet
50mg
Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
453 BRU10110595P Zantac™ Injection 25mg/ml Ranitidine hydrochloride 25mg/ml GlaxoSmithKline Manufacturing
S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
454 BRU10110596P Beconase™ Aqueous Nasal
Spray
Beclomethasone Dipropionate (as
monohydrate)
Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
455 BRU10110597P Campto 40mg/2ml Injection Irinotecan hydrochloride trihydrate
40mg/2ml
Pfizer (Perth) Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
456 BRU10120599PS1;
BRU10120599PS2 JanuviaTM Tablet 25mg Sitagliptin (as phosphate) 25mg Merck Sharp & Dohme (Italia)
S.p.A., Pavia, Italy (S1); Merck
Sharp & Dohme Ltd, England
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
457 BRU10120600P Ritalin® LA Modified Release
Capsule 40mg
Methylphenidate hydrochloride
40mg
Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
458 BRU10120602P Orgalutron Solution for
Injection 0.25mg/0.5ml
Ganirelix acetate 0.25mg/0.5ml Vetter Pharma-Fertigung GmbH &
Co. KG, Germany
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
459 BRU10120604P Afrin Nasal Spray 0.05% Oxymetazoline Hydrochloride
0.05%
PT. Merck Sharp Dohme Pharma
Tbk, Indonesia
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
P
460 BRU10120605P Clarityne Tablet 10mg Loratadine 10mg PT. Merck Sharp Dohme Pharma
Tbk, Indonesia
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
P
461 BRU10120606P Frotin Pessaries Metronidazole 250mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
462 BRU10120607P Allopurinol Tablet 300mg Allopurinol 300mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
463 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mg Astellas Pharma Europe B.V., The
Netherlands
Medipharm Sdn Bhd 29 December 2015 till 28
December 2020
POM
464 BRU10120611P Voren Suppositories 12.5mg Diclofenac Sodium 12.5mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
465 BRU10120612P Flixonase Aqueous Nasal
Spray 0.05%
Fluticasone propionate
(micronised) 50mcg
Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
466 BRU10120613PS1;
BRU10120613PS2
Esmeron® Injection 50mg/5ml
(10mg/ml)
Rocuronium Bromide 50mg/5ml N.V. Organon, The Netherlands;
Hameln Pharmaceuticals GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
BDMCA/RMP/0319 Page 30 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
467 BRU10120615P FlixotideTM EvohalerTM
125mcg
Fluticasone propionate 125mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
468 BRU10120616P Levitra® film-coated Tablet
5mg
Vardenafil 5mg (as
monohydrochloride trihydrate)
Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
469 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
470 BRU11010619PS1;
BRU11010619PS2 JanuviaTM Tablet 100mg Sitagliptin (as phosphate) 100mg Merck Sharp & Dohme (Italia)
S.p.A., Pavia, Italy (S1); Merck
Sharp & Dohme Ltd, England
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
471 BRU11010621P Femara® 2.5mg Tablet Letrozole 2.5mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
472 BRU11010623P Allopurinol Tablet 100mg Allopurinol 100mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
473 BRU11010624P Elomet Ointment 0.1% Mometasone Furoate (as
Anhydrous) USP 0.1%
PT. Merck Sharp Dohme Pharma
Tbk, Indonesia
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
474 BRU11010625 Implanon® 68mg Implant Etonogestrel (Micronised)
[Org3236] 68mg
N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
475 BRU11010626NP Poro Tablet 500mg Paracetamol 500mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 January 2016 till 25
January 2021
P (10 x 10's), P
(100x10's &
3,000's)476 BRU11010627P Tegretol CR 200 Tablet Carbamazapine 200mg Novartis Farma S.p.A., Torree
Annunziata, Italy
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
477 BRU11010628P Oxy-Nase Paediatric Nasal
Spray 0.025%
Oxymetazoline HCl 0.025% HOE Pharmaceuticals Sdn Bhd,
Malaysia
G&H Trading Company 26 January 2016 till 25
January 2021
P
478 BRU11010629P TrandateTM Tablets 100mg Labetalol hyrdochloride 100mg Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
479 BRU11010631P Tegretol® CR 400 Tablet Carbamazapine 400mg Novartis Farma S.p.A., Torree
Annunziata, Italy
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
480 BRU11010632P Comtan® Tablet 200mg Entacapone 200mg Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
481 BRU11010635P Zantac SyrupTM 150mg/10ml Ranitidine (as hydrochloride)
150mg/10ml
Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
482 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 January 2016 till 25
January 2021
P
483 BRU11010637P EngerixTM-B Adult Dose
Vaccine 20mcg/ml
Purified Hepatitis B Surface
Antigen (HBsAg) 20mcg/ml
GlaxoSmithKline Biologicals SA,
Rixensart Belgium;
GlaxoSmithKline Biologicals S.A.,
Wavre Belgium
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
BDMCA/RMP/0319 Page 31 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
484 BRU11010638P HavrixTM720 Junior Vaccine Inactivated Hepatitis A virus
antigen (HAV), HM175 strain 720
EL.U
GlaxoSmithKline Biologicals SA,
Rixensart Belgium;
GlaxoSmithKline Biologicals S.A.,
Wavre Belgium
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
485 BRU11010639P HiberixTM Vaccine Purified polyribosyl-ribitol-
phosphate capsular polyaccharide
(PRP) of Haemophilus influenza
type b (Hib) 10µg covalently bound
to 20-40µg tetanus toxoid
GlaxoSmithKline Biologicals SA,
Belgium; GlaxoSmithKline
Biologicals S.A., Saint-Amand-Les-
Eaux
France
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
486 BRU11010640P Microgynon® 30 Tablet Levonorgestrel 0.15mg,
Ethinylestradiol 0.03mg
Bayer Weimar GmbH und Co., KG,
Germany
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
487 BRU11010642P Virless Tablets 200mg Acyclovir 200mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
488 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride)
300mg
Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
489 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
490 BRU11020645P OroxineTM Tablet 100mcg Levothyroxine (as sodium)
anhydrous 100mcg
Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
491 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5ml Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
492 BRU11020648P Glivec® 100mg Film-coated
Tablet
Imatinib (as mesylate) 100mg Novartis Pharma Produktions
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
493 BRU11020649P Sandostatin® Ampoules
0.05mg/ml
Octreotide (as acetate) 0.05mg/ml Novartis Pharma Stein AG.,
Switzerland
Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
494 BRU11020650P Levitra® film-coated Tablet
20mg
Vardenafil (as monochloride
trihydrate) 20mg
Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
495 BRU11020652P Urosin® Film-coated Tablet
50mg
Atenolol 50mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
496 BRU11020653P Ibuprofen Film-coated Tablet
400mg
Ibuprofen 400mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 February 2016 till 23
February 2021
P
497 BRU11020654P Promethazine Syrup 5mg/5ml Promethazine HCl 5mg/5ml Drug House of Australia Pte Ltd.,
Singapore
G & H Trading Company 24 February 2016 till 23
February 2021
POM
498 BRU11020655P Voren Gel Diclofenac Sodium 10mg/g (as
Diclofenac Acid Diethylamine)
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 February 2016 till 23
February 2021
GSL
499 BRU11020656P Atacor 20mg Film-coated
Tablets
Atorvastatin (as Calcium) 20mg Actavis hf., Iceland K-Seri Pharma Sdn Bhd 24 February 2016 till 23
February 2021
POM
BDMCA/RMP/0319 Page 32 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
500 BRU11020657P Dermosol Cream Clobetasol (as propionate)
0.5%w/w
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
501 BRU11020658P Zendhin 150 Tablet Ranitidine (as hydrochloride)
150mg
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 24 February 2016 till 23
February 2021
POM
502 BRU11030660P Oxy-nase® Nasal Spray 0.05% Oxymetazoline HCl 0.05% HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 26 March 2016 till 25 March
2021
P
503 BRU11030662P Fucon Film Coated Tablet
10mg
Hysocine-n-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
504 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
505 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
506 BRU11030667P Clarinase Syrup 5mg/5ml Per 5ml: Loratadine 5mg,
Pseudoephedrine Sulphate 60mg
Sanofi Aventis Argentina S.A.,
Argentina
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
P
507 BRU11030668P Vivaxim Suspension and
Solution for Suspension for
Injection
Inactivated Hepatitis A Virus, GBM
Strain1,2 ………………………………1603
antigen units1 produced in MRC-5 Human
Diploid Cells2 adsorbed on hydrated aluminium
hydroxide (0.3 milligrams of Al)3 in the absence of an international
standardized reference, the
antigen content is expressed using
an in-house reference.
Vi Capsular Polysaccharide of
Salmonella Typhi (Ty2 Strain)
…...25mcg
Sanofi Pasteur, Parc industriel
d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
508 BRU11030669PS1;
BRU11030669PS2
Caelyx 2mg/ml Concentrate
for Infusion
Doxorubicin HCl 2mg/ml Alza Corporation, USA (S1);
GlaxoSmithKline Manufacturing
S.P.A., Italy (S2)
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
BDMCA/RMP/0319 Page 33 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
509 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH & Co. KG, Germany Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
510 BRU11030671P Hyzaar Forte Tablet 100/25mg Losartan potassium 100mg,
Hydrochlorothiazide 25mg
Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
511 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mg GlaxoSmithKline Pharmaceuticals
S.A., Poland
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
512 BRU11030673P Topistin® Solution for IV
Infusion 200mg/100ml
Ciprofloxacin (as lactate)
200mg/100ml
Elpen Pharmaceutical Co., Inc.,
Greece.
G & H Trading Company 26 March 2016 till 25 March
2021
POM
513 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5ml Glaxo Wellcome Production,
France
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
514 BRU11040675P Puregon® 600iu/0.72ml
Solution for Injection
Recombinant follicle-stimulating
hormone (FSH) (follitrophin beta)
[Org 32489] 600iu/0.72ml
Vetter Pharma-Fertigung GmbH &
Co. KG., Mooswiesen,
Revensburg, Germany and Vetter
Pharma-Fertigung GmbH & Co.
KG., Schutzenstrasse, Ravensburg,
Germany
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
515 BRU11040676PS1;
BRU11040676PS2
Tazocin EF 4.5g Piperacillin (asmonohydrate) 4g;
Tazobactam (as sodium) 0.5g
Wyeth Lederle S.r.I, Catania, Italy
(S1); Pfizer Biotech Corporation,
Hsinchu Plant, Taiwan-Republic of
China (S2)
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
516 BRU11040678P Euvax B Adult Vaccine
Recombinant
Purified HBs-Ag 20mcg LG Chem, Ltd, Korea Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
517 BRU11040679P TrandateTM Injection 5mg/ml x
5ml
Labetalol HCl 25mg/5ml Hsinchu Plant of UBI Pharma Inc.,
Taiwan
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
518 BRU11040680PS2 Puregon® 50IU/0.5ml Solution
for Injection
Follitrophin Beta (recombinant
follicale-stimulating hormone (FSH)
50IU/0.5ml
N.V.Organon, The Netherlands
(S2)
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
519 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride
0.05%w/v
HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 30 April 2016 till 29 April
2021
P
520 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 30 April 2016 till 29 April
2021
POM
521 BRU11040683P Sandostatin® LAR® Injection
10mg
Octreotide 10mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
522 BRU11040684P Vfend TM Film-Coated Tablets
200mg
Voriconazole 200mg Pfizer Italia S.R.L, Italy Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
523 BRU11040685P Voren Suppositories 25mg Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
BDMCA/RMP/0319 Page 34 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
524 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
525 BRU11040689P Shinoxol Tablet 30mg Ambroxol HCl 30mg Y.S.P Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
526 BRU11040690P EngerixTM-B Paediatric Vaccine
10mcg/0.5ml
Purified HBs-Ag 10mcg GlaxoSmithKline Biologicals SA.,
Rixensart Belgium;
GlaxoSmithKline Biologicals S.A.,
Wavre
Belgium
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
527 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 30 April 2016 till 29 April
2021
POM
528 BRU11040693P Cinna Tablet 25mg Cinnarizine 25mg Y.S.P Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
529 BRU11040694P Stalevo® 100/25/200mg Film-
coated Tablet
Levodopa 100mg; Carbidopa
25mg; Entacapone 200mg
Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
530 BRU11040695P RevoladeTM Film-coated Tablet
25mg
Eltrombopag 25mg [as free acid]
(as olamine)
Glaxo Operations UK Ltd (trading
as Glaxo Wellcome Operations),
UK
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
531 BRU11040696P Coversyl® Film-coated Tablet
10mg
Perindopril arginine 10mg (equiv
to perindopril 6.790mg)
Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
532 BRU11040697P Atorvastatin Winthrop® 20mg
Film-coated Tablet
Atorvastatin 20mg (as calcium
20.68mg)
Saneca Pharmaceuticals a.s.,
Slovak Republic
Medipharm Sdn Bhd 30 April 2016 till 29 April
2021
POM
533 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised)
27.5µg /spray
Glaxo Operations UK Ltd, United
Kingdom
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
534 BRU11050700PS1;
BRU11050700PS2
Tetraxim Vaccine Purified diphteria toxoid ≥ 30IU;
purified tetanus toxoid ≥ 40IU;
Bordetella pertusis antigens:
Adsorbed purified pertusis toxoid
25µg, Adsorbed purified
filamentous haemagglutinin 25µg ;
Inactivated poliomyelitis virus:
Type 1 40 D units, Type 2 8 Dunits,
Type 3 32 Dunits.
Sanofi Pasteur, Campus Merieux,
France; Sanofi Pasteur, Parc
industriel d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
535 BRU11050701P Depo-Provera Vial 150mg/3ml Medroxyprogesterone acetate
150mg
Pfizer Manufacturing Belgium
N.V., Belgium
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
BDMCA/RMP/0319 Page 35 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
536 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 25 May 2016 till 24 May
2021
POM
537 BRU11050703P Levitra Film-coated Tablets
10mg
Vardenafil (as monohydrochloride
trihydrate) 10mg
Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
538 BRU11050704P Ventolin Solution for
Intravenous Infusion 5mg/5ml
Salbutamol (as sulphate) 5mg/5ml GlaxoSmithKline Pharmaceutical
S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
539 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mg Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 25 May 2016 till 24 May
2021
P (5 x 50's)
540 BRU11050706P Zofran Injection Flexi-Amp
Ampoules
Ondansetron HCl Dihydrate
8mg/4ml
GlaxoSmithKline Australia Pty
Ltd.m Australia
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
541 BRU11050707P Caverject 20mcg Powder and
solvent for injection
Alprostadil 20µg Pfizer Manufacturing Belgium
N.V., Belgium
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
542 BRU11050708NP Essentiale Forte N Capsule Phospholipids fatty mass 392mg
(equivalent to 300mg
phospholipids from soya beans
containing 76% of (3-sn-
phosphatidyl) choline)
A. Nattermann & Cie. GmbH.,
Germany
Medipharm Sdn Bhd 25 May 2016 till 24 May
2021
GSL (50's)
543 BRU11050710P Coveram Tablets 5mg/5mg Perindopril arginine 5mg (equiv. to
perindopril 3.395mg); Amlodipine
5mg (as besilate 6.935mg)
Servier (Ireland) Industries Ltd.,
Ireland
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
544 BRU11050712P Tracrium Injection
25mg/2.5ml
Atracurium besylate 25mg/2.5ml GlaxoSmithKline Manufactuirng
S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
545 BRU11060714P Zantac 150mg Tablet Ranitidine 150mg (as HCl 168mg) GlaxoSmithKline (Tianjin) Co. Ltd.,
PR China
Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
546 BRU11060715P Oxy-Nase Paediatric Nasal
Drop 0.025%w/v
Oxymetazoline HCl 0.025% HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 02 July 2016 till 01 July 2021 POM
547 BRU11060716P Vfend 50mg film-coated
Tablet
Voriconazole 50mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
548 BRU11060717P Protaxos 2g Strontium Ranelate 2632mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
549 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH & Co. KG, Germany Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
550 BRU11060720P Virless Tablet 800mg Acyclovir 800mg Y.S.P. Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
BDMCA/RMP/0319 Page 36 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
551 BRU11060721P Atorvastatin Winthrop® 40mg
Tablet
Atorvastatin 40mg (as Calcium
41.36mg)
Saneca Pharmaceuticals a.s.,
Slovak Republic
Medipharm Sdn Bhd 02 July 2016 till 01 July 2021 POM
552 BRU11060722P Propecia 1mg Tablet Finasteride 1mg Merck Sharp & Dohme, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
553 BRU11060723P Seroquel XR Extended-Release
Tablets 50mg
Quetiapine 50mg (as fumarate
57.560mg)
AstraZeneca Pharmaeuticals LP,
USA
Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
554 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mg Astella Pharma Europe B.V., The
Netherlands
Medipharm Sdn Bhd 27 July 2016 till 26 July 2021 POM
555 BRU11070727P SW Bena-Expectorant Per 5ml: Diphenhydramine HCl
10mg, Ammonium Chloride
102mg, Sodium Citrate 46mg
Sunward Pharmaceutical Pte Ltd.,
Singapore
G&H Trading Company 27 July 2016 till 26 July 2021 POM
556 BRU11070729P Priorix TM Composition of Priorix™ per dose
(0.5ml): Live attenuated measles
virus (Schwarz strain) ≥103.0 CCID50,
Live attenuated mumps virus
(RIT4385 strain) ≥103.7 CCID50, Live
attenuated rubella virus (Wistar RA
27/3 strain) ≥103.0 CCID50
GlaxoSmithKline Biologicals s.a.,
Belgium; FIDIA Farmaceutici S.p.a.,
Italy
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
557 BRU11070730P Mirena® Intrauterine System
20mcg/24hr
Levonorgestrel 52mg Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
558 BRU11070732PS1;
BRU11070732PS2
Zoral 400 Tablet 400mg Acyclovir USP 400mg Drug House of Australia Pte Ltd.,
Singapore (S1); PT Actavis
Indonesia, Jakarta, Indoensia (S2)
G & H Trading Company 27 July 2016 till 26 July 2021 POM (7 x 10’s
blister pack);
(10 x 10 x 10’s
blister pack - for
DHA only)
559 BRU11070733P ZofranTM Injection 4mg/2ml Ondansetron 4mg/5ml (as HCl
dihydrate)
GlaxoSmithKline Australia Pty Ltd.,
Australia
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
560 BRU11070734P Syntometrine® Injection
5IU/ml Ampoule
Oxytocin 5IU/ml Novartis Pharma Steing AG.,
Switzerland
Medipharm Sdn Bhd 27 July 2016 till 26 July 2021 POM
561 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/w HOE Pharmaceuticals Sdn Bhd.,
Malaysia
G & H Trading Company 27 July 2016 till 26 July 2021 POM
562 BRU11070736P Coveram 5/10mg Tablet Perindopril arginine 5mg (equiv. to
3.395mg perindopril) and
amlodipine 10mg (as besilate
13.870mg)
Servier (Ireland) Industries Ltd,
Ireland
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
BDMCA/RMP/0319 Page 37 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
563 BRU11070737P ZofranTM Tablets 8mg Ondansetron 8mg (as HCl
dihydrate)
Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
564 BRU11070738PS1;
BRU11070738PS2
Diamicron® MR 60mg Tablet Gliclazide 60mg Les Laboratoires Servier Industrie,
France (S1); Kotra Pharma (M)
Sdn. Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
565 BRU11070739P Fedac DM Linctus Per 5ml: Triprolidine HCl 12.5mg,
Pesudoephedrine HCl 30mg,
Dextrometorphan HBr 10mg
Drug House of Australia Pte Ltd.,
Singapore
G & H Trading Company 27 July 2016 till 26 July 2021 POM
566 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5ml GlaxoSmithKline Manufacturing
S.p.A., Parma, Italy
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
567 BRU11070741P Coralan® Tablet 7.5mg Ivabradine 7.5mg (as HCl 8.085mg) Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
568 BRU11080742P;
BRU11080742PS2
Aclasta 5mg/10ml Solution for
Infusion
Zolendranic acid (anhydrous) 5mg
(as zolendranic acid monohydrate
5.33mg)
Novartis Pharma Stein AG.,
Switzerland; Fresenius Kabi
Austria GmbH, Austria (S2)
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
569 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcg Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
570 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mg Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
571 BRU11080745P Glivec® 400mg Film-coated
Tablet
Imatinib (as mesylate) 400mg Novartis Pharma Stein AG.,
Switzerland
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
572 BRU11080746P Stalevo 50/12.5/200mg film-
coated tablet
Levodopa 50mg, Carbidopa
12.5mg, Entacapone 200mg
Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
573 BRU11080747PS1,
BRU11080747PS2,
BRU11080747PS3
Pentaxim Vaccine Composition of final container per
dose (0.5ml): TETRAXIM - Purified
diphteria toxoid ≥ 30 I.U; Purified
tetanus toxoid ≥40 I.U; Adsorbed
purified pertusis toxoid 25µg;
Inactivated poliomyeltis virus
type1 40 DU, type 2 8DU, type 3 32
DU; Act-HIB - Polysaccharide of
Haemophilus influenza type b
conjugated to tetanus protein
10µg
Sanofi Pasteur, Campus Merieux,
Marcy I'Etoile, France (S1); Sanofi
Pasteur, Parc Industriel
d'Incarville, France (S2); Sanofi
Pasteur, Gruppo Lepeptit, Angani,
Italy (S3)
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
BDMCA/RMP/0319 Page 38 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
574 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydrate Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
575 BRU11080749P Econazine Cream Econazole nitrate 1% w/w,
Triamcinolone actonide 0.1% w/w
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
576 BRU11080750P Frotin Film Coated 200mg
Tablet
Metronidazole 200mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
577 BRU11080751P Urosin Film Coated Tablet
100mg
Atenolol 100mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
578 BRU11080752P TwinrixTM Vaccine Hepatitis A virus antigen 720 ELISA
units; r-DNA hepatitis B virus
surface antigen (HBsAg)* 20µg
*Thiomersal-free HBsAg purified
bulk
GlaxoSmithKline Biologicals SA,
Rixensart, Belgium
(Responsibilities: Manufacturer of
finished products);
GlaxoSmithKline Biologicals S.A.,
Saint-Amand-Les-Eaux, France
(Responsibilities: Repacker of
finished products);
GlaxoSmithKline Biologicals S.A.,
Wavre, Belgium (Responsibilities:
Additional facility for formulation
of non-live vaccines);
GlaxoSmithKline Biologicals,
Dresden, Germany
(Responsibilities: Additional
facility for syringe filling,
packaging and labelling)
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
579 BRU11080753P Fukole Capsule 150mg Fluconazole 150mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
580 BRU11080754P CoAprovel Tablet 300/25mg Irbesartan 300mg,
Hydrochlorothiazide 25mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 25 August 2016 till 24
August 2021
POM
581 BRU11080757P Orphenadol® Tablet Orphenadrine Citrate 50mg,
Paracetamol 325mg
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
582 BRU11080758P Loramide Capsule 2mg Loperamide HCl 2mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
583 BRU11080759P VOREN Suppositories 50mg Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
BDMCA/RMP/0319 Page 39 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
584 BRU11080760P Decan Tablet 0.75mg Dexamethasone 0.75mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 25 August 2016 till 24
August 2021
POM
585 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 27 September 2016 till 26
September 2021
POM
586 BRU11090763P Infanrix HexaTM Composition of reconstiitiuted
DTPa-HBV-IPV+Hib Vaccine per
dose (0.5ml): Diphteria toxoid min.
30 I.U; Tetanus toxoid min. 40 I.U;
Pertusis toxoid (PT) 25µg;
Filamentous haemagglutinin (FHA),
adsorbed 25µg; Pertactin,
adsorbed 8µg; r-DNA Hepatitis B
surface antigen (HBsAg purified)
10µg; Inactivated poliomyeltis
virus type I 40 DU, Inactivated
poliomyeltis virus type II 8DU,
Inactivated poliomyeltis virus type
III 32 DU;Conjugate of
Haemophilus influenza type b
capsular polysaccharide (PRP) and
tetanus toxoid 10µg PRP and
~25µg T
GlaxoSmithKline Biologicals SA,
Rixensart Belgium;
GlaxoSmithKline Biologicals S.A.,
Saint-Amand-Les-Eaux
France; GlaxoSmithKline
Biologicals S.A., Wavre
Belgium;
Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
587 BRU11090764P Eloxatin 5mg/ml Concentrate
for Solution for Infusion
(10ml)
Oxaliplatin 50mg/10ml Sanofi-Aventis Deutschland
GmbH, Germany
Medipharm Sdn Bhd 27 September 2016 till 26
September 2021
POM
588 BRU11090765P Eloxatin 5mg/ml Concentrate
for Solution for Infusion
(20ml)
Oxaliplatin 100mg/20ml Sanofi-Aventis Deutschland
GmbH, Germany
Medipharm Sdn Bhd 27 September 2016 till 26
September 2021
POM
BDMCA/RMP/0319 Page 40 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
589 BRU11090766P InfanrixTM-IPV Vaccine Composition per dose (0.5ml):
Diphteria toxoid (DT), adsorbed
min. 30 I.U; Tetanus toxoid (TT),
adsorbed min. 40 I.U; Pertusis
toxoid (PT), adsorbed 25µg;
Filamentous haemagglutinin (FHA),
adsorbed 25µg; Pertactin,
adsorbed 8µg; Inactivated
poliomyeltis virus type I 40 DU,
Inactivated poliomyeltis virus type
II 8DU, Inactivated poliomyeltis
virus type III 32 DU
GlaxoSmithKline Biologicals SA,
Belgium (Manufacturer of finished
products); GlaxoSmithKline
Biologicals S.A. France (Repacker
of finished products, additional
facilities for formulation, filling
and quality control testing sites)
Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
590 BRU11090767P Sandimmun Neoral® Oral
Solution 100mg/ml
Ciclosporin A 100mg/ml Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
591 BRU11090768P Hyzaar® Tablet 50/12.5mg Losartan Potassium 50mg,
Hydrochlorothiazide 12.5mg
Merck Sharp & Dohme,
Northumberland, UK
Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
592 BRU11090769P Hyzaar® Plus Tablet
100/12.5mg
Losartan Potassium 100mg,
Hydrochlorothiazide 12.5mg
Merck Sharp & Dohme,
Northumberland, UK
Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
593 BRU11090770P Flebogamma 5% DIF Solution
for Infusion (100mL)
Human Normal Immunoglobulin
50mg/ml
Instituo Grifols S.A., Barcelona,
Spain
Hongkiat Trading & Company 27 September 2016 till 26
September 2021
POM
594 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mg AstraZeneca Pharmaeuticals LP,
USA
Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
595 BRU11090772P Diabetamin Film-coated
Tablet 500mg
Metformin HCl 500mg Hovid Bhd, Perak, Malaysia G & H Trading Company 27 September 2016 till 26
September 2021
POM
596 BRU11090773P Tidact Gel 1% Clindamycin 10mg/g (as phosphate
11.9mg/g)
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
597 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
598 BRU11090775P Fucon Capsule 10mg Hyoscine-N-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
599 BRU11090776P Virless Cream Acyclovir 50mg/g Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
600 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate
6.90mg)
Hovid Bhd, Malaysia G & H Trading Company 27 September 2016 till 26
September 2021
POM
601 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mg Bushu Pharmaceuticals Ltd, Japan.
, Japan
MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
BDMCA/RMP/0319 Page 41 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
602 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mg Bushu Pharmaceuticals Ltd, Japan.
, Japan
MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
603 BRU11100781PS2 Puregon® 100IU/0.5ml
Solution for Injection
Follitropin beta (recombinant
follicle-stimulating hormone - FSH)
100IU/0.5ml
N.V. Organon, The Netherlands
(S2)
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
604 BRU11100782P Gardasil Vaccine HPV Type 6 L1 protein
20mcg/0.5ml; HPV Type 11 L1
protein 40mcg/0.5ml; HPV Type 16
L1 protein 40mcg/0.5ml; HPV Type
18 L1 protein 20mcg/0.5ml
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
605 BRU11100784P Sandostatin® ampoules
0.1mg/ml
Octreotide (as acetate) 0.1mg/ml Novartis Pharma Stein A.G.,
Switzerland
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
606 BRU11100785P Atorvastatin Winthrop® 10mg
film-coated Tablets
Atorvastatin 10mg (as calsium
10.34mg)
Saneca Pharmaceuticals a.s.,
Slovak Republic
MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
607 BRU11100786P Stalevo® 150/37.5/200mg
Film-coated Tablet
Levodopa 150mg; Carbidopa
37.5mg; Entacapone 200mg
Orion Corporation Fermion,
Finland
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
608 BRU11100787P Coveram Tablet 10mg/5mg Perindopril arginine 10mg (eqv. To
Perindopril 6.790mg); Amlodipine
5mg (as besilate 6.935mg)
Servier (Ireland) Industries Ltd.,
Ireland
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
609 BRU11100788P Coversyl® Fim-coated Tablet
5mg
Perindopril arginine 5mg (eqv.
Perindopril 3.395mg)
Les Laboratoires Servier Industrie,
Gidy, France
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
610 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mg Eisai Co., Ltd, Saitama Prefecture,
Japan
MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
BDMCA/RMP/0319 Page 42 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
611 BRU11100790P VarilrixTM Live attenuated varicella virus
(OKA strain)
GlaxoSmithKline Biologicals SA,
Rixensart, Belgium
(Manufacturer of finished
product); (Corixa Corporation dba
GlaxoSmithKline Vaccines, USA
(formulation, filling, lyophilisation
and QC testing)
GlaxoSmithKline Biologicals SA,
Rixensart, Belgium (Manufacturing
site for Water for Injection (WFI)
diluents in syringe and ampoule);
Delpharm Tours, Chambray-lès-
Tours, France (Manufacturing site
for Water for Injection (WFI)
diluents in ampoules);
GlaxoSmithKline Biologicals S.A.,
Wavre, Belgium
& GlaxoSmithKline Biologicals,
Saint-Amand-Les-Eaux, France &
Centre de Recherche et de
Nouvelles Applications (CRNA) SA,
Belgium (Manufacturing site for
final packaging operations)
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
612 BRU11100791P Coveram Tablet 10mg/10mg Perindopril arginine 10mg (eqv. To
Perindopril 6.790mg); Amlodipine
10mg (as besilate 13.870mg)
Servier (Ireland) Industries Ltd.,
Ireland
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
613 BRU11100792P Voker Film Coated Tablet
20mg
Famotidine 20mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
614 BRU11100794P Clarityn-D 12HR EXTENDED
RELEASE TABLET 5mg/120mg
Loratadine 5mg, Pseudoephedrine
sulphate 120mg
Schering Plough Labo N.V.,
Belgium
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
BDMCA/RMP/0319 Page 43 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
615 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcg Merck KGaA., Darmstadt,
Germany
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
616 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mg Merck KGaA., Darmstadt,
Germany
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
617 BRU11110797P OnglyzaTM Tablet 2.5mg Saxagliptin 2.5mg (as HCl
anhydrous 2.79mg)
Bristol-Myers Squibb Company,
Indiana, USA
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
618 BRU11110798P OnglyzaTM Tablet 5mg Saxagliptin 5mg (as HCl anhydrous
5.58mg)
Bristol-Myers Squibb Company,
Indiana, USA
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
619 BRU11110799P Sandostatin® LAR® Injection
20mg
Octreotide (as acetate) 20mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
620 BRU11110800P Sandostatin® LAR® Injection
30mg
Octreotide (as acetate) 30mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
621 BRU11110802P GardasilTM Vaccine (Syringe) Per 0.5ml dose - HPV Type 6 L1
protein 20mcg; HPV Type 11 L1
protein 40mcg; HPV Type 16 L1
protein 40mcg; HPV Type 18 L1
protein 20mcg
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
622 BRU11110803P Nexavar® 200mg Film-coated
Tablets
Sorafenib Tosylate 200mg Bayer Pharma AG., Leverkusen,
Germany; Bayer Healthcare
Manufacturing S.r.l., Italy
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
623 BRU11110804P PEG Intron CLEARCLICK for
Injection 150mcg/0.5ml
Recombinant interferon alfa-2b
150mcg (pegylated to monoethoxy
polyethylene glycol)
MSD International GmbH
(Singapore Branch), Singapore
Singapore
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
624 BRU11110805P PEG Intron CLEARCLICK for
Injection 120mcg/0.5ml
Recombinant interferon alfa-2b
120mcg (pegylated to monoethoxy
polyethylene glycol)
Schering-Plough Ltd., Singapore Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
625 BRU11110806P PEG Intron CLEARCLICK for
Injection 100mcg/0.5ml
Recombinant interferon alfa-2b
100mcg (pegylated to monoethoxy
polyethylene glycol)
MSD International GmbH
(Singapore Branch), Singapore
Singapore
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
626 BRU11110807P PEG Intron CLEARCLICK for
Injection 80mcg/0.5ml
Recombinant interferon alfa-2b
80mcg (pegylated to monoethoxy
polyethylene glycol)
MSD International GmbH
(Singapore Branch), Singapore
Singapore
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
BDMCA/RMP/0319 Page 44 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
627 BRU11110808P PEG Intron CLEARCLICK for
Injection 50mcg/0.5ml
Recombinant interferon alfa-2b
50mcg (pegylated to monoethoxy
polyethylene glycol)
MSD International GmbH
(Singapore Branch), Singapore
Singapore
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
628 BRU11110809P Dalacin CTM Sterile Solution
150mg/ml x 2ml ampoule
Clindamycin Phosphate 300mg Pfizer Manufacturing Belgium
N.V., Puurs, Belgium
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
629 BRU11110811P Aricept® Tablet 5mg Donepezil HCl 5mg (equiv. to
Donepezil free base 4.56mg)
Eisai Taiwan Inc., Tainan Hsien,
Taiwan
MediPharm Sdn Bhd 24 November 2011 till 23
November 2016
POM
630 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcg Merck KGaA., Darmstadt,
Germany
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
631 BRU11110813P Ketipinor Film-coated Tablet
200mg
Quetiapine 200mg (as fumarate
230.36mg)
Orion Corporation, Espoo, Finland Hongkiat Trading & Company 24 November 2016 till 23
November 2021
POM
632 BRU11110814P Prednisolone Tablet 5mg Prednisolone 5mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
633 BRU11110815P Granocyte® 34 Injection Lenograstim (rHug-CSF) 33.6
million IU (equiv. to 263 mcg)/ vial
Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 24 November 2016 till 23
November 2021
POM
634 BRU11120816P Euvax B Pediatric Vaccine
Recombinant (10mcg/0.5ml)
Purified HBs-Ag 10mcg/0.5ml LG Chem, Ltd, Korea Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
635 BRU11120817P Puregon® 300IU/0.36 ml
Solution for Injection
Recombinant follicle-stimulating
hormone (FSH) (follitrophin beta)
[Org 32489] 600iu/0.72ml
Vetter Pharm-Fertigung GmbH &
Co. KG., Schutzenstrasse,
Ravensburg, Germany: Vetter
Pharm-Fertigung GmbH & Co. KG.,
Mooswiesen, Ravensburg,
Germany; Vetter Pharma-
Fertigung GmbH & Co. KG,
Eisenbahnstrasse, Langenargen,
Germany and Vetter Pharma-
Fertigung GmbH & Co. KG,
Holbeinstrassee, Ravensburg
Germany
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
636 BRU11120818P Clarityn Syrup Loratadine 1mg/ml PT. Merck Sharp Dohme Pharma
Tbk, Indonesia
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
P
BDMCA/RMP/0319 Page 45 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
637 BRU11120819P0.5gV
&
BRU11120819P0.5gS
SynflorixTM Vaccine 1 dose (0.5ml) contains:
Pneumococcal polysaccharide
serotype 11,2 - 1mcg,
Pneumococcal polysaccharide
serotype 41,2 - 3mcg, Pneumococcal
polysaccharide serotype 51,2 -
1mcg, Pneumococcal
polysaccharide serotype 6B1,2 -
1mcg, Pneumococcal
polysaccharide serotype 7F1,2 -
1mcg, Pneumococcal
polysaccharide serotype 9V1,2 -
1mcg, Pneumococcal
polysaccharide serotype 141,2 -
1mcg, Pneumococcal
polysaccharide serotype18C1,3 -
3mcg, Pneumococcal
polysaccharide serotype 19F1,4 -
3mcg, Pneumococcal
polysaccharide serotype 23F1,2 -
1mcg
Note: 1 adsorbed on aluminium
phosphate - 0.5mg Al3+; 2
conjugated to protein D (derived
from non-typeable Haemophilus
influenza) carrier protein - 9-
16mcg; 3 conjugated to tetanus
toxoid carrier protein - 5-10mcg; 4
GlaxoSmithKline Biologicals SA,
Rixensart Belgium; Glaxo
SmithKline Biologicals SA, Saint-
Amand-Les-Eaux
France
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
638 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg)
100mcg
Glaxo Wellcome S.A., Burgos,
Spain
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
639 BRU11120822P RevoladeTM Film-coated
Tablets 50mg
Eltrombopag olamine (eq. to
Eltrombopag 50mg as Eltrombopag
free acid)
Glaxo Operations UK Ltd (trading
as Glaxo Wellcome Operations)
United Kingdom
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
BDMCA/RMP/0319 Page 46 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
640 BRU11120823P Coversyl® Plus 5mg Perindopril arginine 5mg (as
besilate 3.395mg); Indapamide
1.25mg
Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
641 BRU11120824P Yasmin® Film-coated Tablets Drospirenone 3mg, Ethinylestradiol
0.03mg
Bayer Weimar GmbH und Co. KG
(WEIMAR PLANT), Germany
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
642 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
GSL
643 BRU11120827P Methycobal Injection
500mcg/ml
Mecobalamin 500mcg Bushu Pharmaceuticals Ltd, Japan MediPharm Sdn Bhd 22 December 2016 till 21
December 2021
POM
644 BRU11120828P Flebogamma® 5% DIF Solution
for Infusion (200ml)
Human Normal Immunoglobulin
10g/200mL (50mg/ml)
Instituto Grifols, S.A., Spain Hongkiat Trading 22 December 2016 till 21
December 2021
POM
645 BRU11120829P Shintamet film coated Tablet Cimetidine 400mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
646 BRU11120830P Dermafin cream 1% Terbinafine Hydrochloride 1%w/w Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
GSL
647 BRU11120831P Pontalon Tablet 250mg Mefenamic Acid 250mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
648 BRU11120832P Clopivid Tablet 75mg Clopidogrel 75mg (as hydrogen
sulphate 97.90mg)
Hovid Bhd, Malaysia G & H Trading Company 22 December 2016 till 21
December 2021
POM
649 BRU11120833P Shincort Injection “Yung Shin”
10mg/ml
Triamcinolone Acetonide
50mg/5ml
Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan ROC
Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
650 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate
13.8mg)
Hovid Bhd, Malaysia G & H Trading Company 22 December 2016 till 21
December 2021
POM
651 BRU11120835P Indomen Capsule 25mg Indomethacin 25mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
652 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
653 BRU11120837P Primacor® 10mg/10ml
Injection
Milrinone 10mg/10ml (as lactate) Delpharm Dijon, France MediPharm Sdn Bhd 22 December 2016 till 21
December 2021
POM
654 BRU11120838NP Champs D-Worms 6 Chewable
Tablet (Chocolate)
Albendazole 200mg Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 22 December 2016 till 21
December 2021
GSL (2's)
655 BRU11120839P Epilim® 200 Enteric Coated
Tablets
Sodium Valproate 200mg Sanofi-Aventis S.A., Spain MediPharm Sdn Bhd 22 December 2016 till 21
December 2021
POM
BDMCA/RMP/0319 Page 47 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
656 BRU12010840P InfanrixTM-IPV+Hib Vaccine
(DTPa-IPV+Hib)
1 dose (0.5ml) contains: Diphteria
toxoid (DT) Min 30 I.U.; Tetanus
toxoid (TT) Min 40 I.U.; Pertussis
toxoid (PT) Min 25mcg;
Filamentous haemagglutinin (FHA)
25mcg; Pertactin (69Kda Outer
membrance protein) 8mcg;
Inactivated Polio Virus Type 1
(Mahoney seed) 40DU; Inactivated
Polio Virus Type 2 (MEF-1 seed)
8DU; Inactivated Polio Virus Type 3
(Saukett seed) 32DU; Conjugate of
purified capsular polysaccharide
(10mcg) of Haemophilus influenza
type b covalently bound to
approximately 30mcg to 50 mcg
tetanus toxoid
GlaxoSmithKline Biologicals SA,
Rixensart Belgium;
GlaxoSmithkline Biologicals S.A.,
France
Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
657 BRU12010841P Cardura XLTM tablet 4mg Doxazosin Mesylate 4mg Pfizer Pharmaceuticals LLC, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
658 BRU12010842P Valdoxan® 25mg film-coated
tablet
Agomelatine 25mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
659 BRU12010843P Zofran Tablet 4mg Ondansetron (as Hydrochloride
Dihydrate) 4mg
Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
660 BRU12010844P Flebogamma® 5% DIF Solution
for Infusion (50ml)
Human Normal Immunoglobulin
2.5g/50mL (50mg/ml)
Instituto Grifols, S.A., Spain Hongkiat Trading & Co 01 February 2017 till 31
January 2022
POM
661 BRU12010845P Coralan® Tablet 5mg Ivabradine 5mg eq. to 5.39mg
ivabradine hydrochloride
Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
662 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mg Astrazeneca Pharmaceuticals LP,
USA
Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
663 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mg Astrazeneca Pharmaceuticals LP,
USA
Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
664 BRU12010850P Enapril tablet 10mg Enalapril maleate 10mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
BDMCA/RMP/0319 Page 48 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
665 BRU12010851NP Princi-B Fort® tablet Thiamin mononitrate 250mg,
Pyridoxine hydrochloride 250mg &
Cyanocobalamin 1mg
Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd 01 February 2017 till 31
January 2022
P
666 BRU12010852P Antifungal Cream 2% Miconazole Nitrate 20mg/g (2%
w/w)
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 01 February 2017 till 31
January 2022
GSL
667 BRU12010853P Concor® 5mg tablet Bisoprolol hemifumarate 5mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
668 BRU12010854P Ketipinor film-coated tablet
100mg
Quetiapine (as fumarate
115.13mg) 100mg
Orion Corporation, Finland Hongkiat Trading & Co 01 February 2017 till 31
January 2022
POM
669 BRU12010855P Euthyrox® Tablet 50mcg Levothyroxine sodium 50mcg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
670 BRU12010856NP Panadol Suspension
250mg/5ml
Paracetamol 250mg/5ml Smithkline Beecham, Philippines Kingston Beverage &
Creamery Sdn Bhd
01 February 2017 till 31
January 2022
GSL
(60ml/120ml)671 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml
(200mg/vial)
Sanofi S.p.A, Italy MediPharm Sdn Bhd 01 February 2017 till 31
January 2022
POM
672 BRU12020858P Sebivo™ Tablet 600mg Telbivudine 600mg Novartis Pharma Stein AG.,
Switzerland
Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
673 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
674 BRU12020862P Ketipinor Film-coated Tablet
25mg
Quetiapine (as fumarate 28.78mg)
25mg
Orion Corporation, Finland Hongkiat Trading & Co 1 March 2017 till 28
February 2022
POM
675 BRU12020863P Taxotere 20mg/1ml
concentrate for solution for
infusion
Docetaxel (as trihydrate) 20mg/ml Sanofi-Aventis Deutschland
GmbH, Germany
MediPharm Sdn Bhd 1 March 2017 till 28
February 2022
POM
676 BRU12020864P Zanidip® Tablet 10mg Lercanidipine Hydrochloride 10mg
(eq. to 9.4mg Lercanidipine)
Recordati Industria Chimica &
Farmaceutica S.p.A, Italy
Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
677 BRU12020865PS1 Nifedipine LA Tablet 30mg Nifedipine 30mg Valpharma International S.p.A,
Italy (S1);
G & H Trading Company 1 March 2017 till 28
February 2022
POM
678 BRU12020866P Apidra® Solostar®
100units/ml, Solution for
Injection in a Pre-filled Pen
Insulin Glulisine 100units/ml Sanofi-Aventis Deutschland
GmbH, Germany
MediPharm Sdn Bhd 1 March 2017 till 28
February 2022
POM
679 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
680 BRU12020868P Betnovate™ Cream Betamethasone 0.1%w/w (as
Betamethasone 17-Valerate BP
0.122% w/w)
Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
BDMCA/RMP/0319 Page 49 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
681 BRU12020869P Dermovate™ Cream Clobetasol (as propionate) 0.05%
w/w
Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
682 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing Deutshland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
683 BRU12030871NP Panadol® Menstrual Caplet Paracetamol 500mg & Pamabrom
25mg
Sterling Drug (Malaya) Sdn Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 March 2017 till 29 March
2022
P (12 x 10's)
684 BRU12030872NP Panaflex® Pain Relief Patch Glycol Salicylate 1.5%w/w, L-
Menthol 1.0% w/w, DL-Camphor
0.5%w/w, DL-A-Tocopherol
Acetate 0.3%w/w
Teh Seng Pharmaceutical Mfg Co.,
Ltd., Taiwan, ROC
Kingston Beverage &
Creamery Sdn Bhd
30 March 2017 till 29 March
2022
GSL
685 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., Sweden Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
686 BRU12030875P DetrusitolTM SR Capsule 4mg Tolterodine L-Tartrate 4mg
(equivalent to Tolterodine 2.74mg)
Catalent Pharma Solutions LLC,
USA
Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
687 BRU12030876NP Ellgy Corns & Warts
Treatment Solution
Salicylic acid 17%w/v HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 30 March 2017 till 29 March
2022
P
688 BRU12030877P Puregon® 900IU/1.08ml
Solution for Injection
Follitropin Beta (Recombinant
follicle-stimulating hormone FSH)
[Org 32489]
Vetter Pharma-Fertigung GmbH &
Co. KG., Schutzenstrasse,
Ravensburg, Germany; Vetter
Pharma-Fertigung GmbH & Co.
KG., Mooswiesn2, Ravensburg,
Germany; Vetter Pharma-
Fertigung GmbH & Co. KG.,
Eisenbahnstrasse, Langenargen,
Germany; Vetter Pharma-
Fertigung GmbH & Co. KG.,
Holbeinstrasse, Ravensburg,
Germany
Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
689 BRU12030879P Methotrexate Injection BP
50mg in 2ml
Methotrexate 50mg/2ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
690 BRU12030880NP Aqua Cream Emulsifying Wax 8% w/w, White
Soft Paraffin 12%w/w, Liquid
Paraffin 8%w/w
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 30 March 2017 till 29 March
2022
GSL
691 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mg Pfizer Pharmaceuticals LLC., vega
Baja Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
692 BRU12030882P Cancidas Powder for Injection
50mg/vial
Caspofungin (as acetate) 50mg/vial Laboratoires Merck Sharp &
Dohme Chibret, France
Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
BDMCA/RMP/0319 Page 50 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
693 BRU12030883P Axcel Dextrozine Syrup Dextromethorphan Hydrobromide
15mg/5ml; Promethazine HCl
3.6mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 March 2017 till 29 March
2022
POM
694 BRU12040884P Dilantin Steri Vials 250mg in
5ml
Phenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April
2022
POM
695 BRU12040885P Jevtana® 60mg Concentrate
and Solvent for Solution for
Infusion
Cabazitaxel 60mg/1.5ml Sanofi-Aventis Deutschland
GmbH, Germany
Medipharm Sdn Bhd 30 April 2017 till 29 April
2022
POM
696 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride) GlaxoSmithKline Manufacturing
S.p.A., Parma, Italy
Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April
2022
POM
697 BRU12040887NP Panadol Suspension
120mg/5ml
Paracetamol 120mg/5ml SmithKline Beecham, Cainta Rizal,
Philippines
Kingston Beverage &
Creamey Sdn Bhd
30 April 2017 till 29 April
2022
GSL (60ml
& 120ml)698 BRU12040888P Cancidas Powder for Injection
70mg/vial
Caspofungin (as acetate) 70mg/vial Laboratoires Merck Sharp &
Dohme Chibret, France
Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April
2022
POM
699 BRU12040889PS1 &
BRU12040889PS2
Nasonex Aqueous Nasal Spray
0.05%
Mometasone furorate
monohydrate, micronized 0.05%
Schering-Plough Labo N.V.,
Belgium (S1) & MSD International
GmbH (Singapore Branch),
Singapore (S2)
Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April
2022
POM
700 BRU12040891P Axcel Diprodin Elixir Diphenhydramine HCl 12.5mg/5ml;
Ephedrine HCl 6mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
701 BRU12040892NP Axcel Paracetamol-120 Syrup
(Cherry)
Paracetamol 120mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
GSL (60ml &
100ml)702 BRU12040893P Axcel Clobetasol 0.05% Cream Clobetasol propionate 0.05%w/w Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
703 BRU12040894P Axcel Tridine Syrup Triprolidine HCl 1.25mg/5ml;
Pseudoephedrine HCl 30mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
704 BRU12040895P Axcel Lignocaine Sterile Gel
2%w/w
Lignocaine HCl (Equiv. to
anhydrous HCl) 2g/100g
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
705 BRU12050897P VfendTM IV 200mg Voriconazole 200mg Pharmacia & Upjohn Company,
USA (Repacker - Fareva Amboise,
France)
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
BDMCA/RMP/0319 Page 51 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
706 BRU12050898P Lamictal Dispersible Tablet
5mg
Lamotrigine 5mg GlaxoSmithKline Pharmaceuticals
SA., Poznan, Poland (Repacker -
GlaxoSmithKline Australia Pty Ltd.,
ViCtoria, Australia)
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
707 BRU12050899P HycamtinTM Hard Capsule
0.25mg
Topotecan 0.25mg (as
hydrochloride)
GlaxoSmithKline Manufacturing
S.p.A., Parma, Italy
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
708 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/ml Schering-Plough Labo N.V.,
Belgium
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
709 BRU12050901NP Flamazine Cream 1% w/w Silver Sulfadiazine 1.0%w/w Recipharm Parets S.L., Barcelona,
Spain
Mc Quipp Technisell
Marketing Sdn Bhd
24 May 2017 till 23 May
2022
P
710 BRU12050902P AeriusTM Tablets 5mg Desloratadine 5mg Schering-Plough Labo N.V.,
Belgium
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
711 BRU12050903NP Panadol® ActiFast Caplets Paracetamol 500mg GlaxoSmithKline Dungravan Ltd,
Ireland (Repacker - Sterling Drug
(Malaya) Sdn Bhd., Malaysia
Kingston Beverage &
Creamery Sdn Bhd
24 May 2017 till 23 May
2022
P ( 48's; 80's (8
tabs per blister)
per box)
712 BRU12050904P Vaxcel Heparin Sodium
Injection 5000 IU/ml x 5ml
Heparin Sodium (Bovine mucosa)
25,000/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 24 May 2017 till 23 May
2022
POM
713 BRU12050905P Pregnyl® 5000IU Powder and
Solvent for Injection
Human chorionic gonadotrophin
5000IU/ampoule
Diluent-0.9% sodium chloride
N.V. Organon, The Netherlands;
Jubilant HolisterStier LLC, USA
(manufacturer of diluent - Sodium
chloride)
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
714 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mg Bushu Pharmaceuticals Ltd, Japan Medipharm Sdn Bhd 30 June 2017 till 29 June
2022
POM
715 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mg Pfizer Manufacturing Deutschland
GmbH, Freiburg, Germany
Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June
2022
POM
716 BRU12060910NP Panadol® Soluble Tablet
500mg
Paracetamol 500mg GlaxoSmithKline Australia Pty Ltd,
Ermington, NSW, Australia
Kingston Beverage &
Creamery Sdn Bhd
30 June 2017 till 29 June
2022
GSL
(20's) & P (144's)
717 BRU12060911NP Panadol For Children Tablets
120mg
Paracetamol 120mg Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 June 2017 till 29 June
2022
P (24's &
144's)718 BRU12060912P Canesten GYN 1 Day Therapy
Vaginal Tablet 0.5g
Clotrimazole 500mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June
2022
POM
BDMCA/RMP/0319 Page 52 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
719 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mg Corden Pharma GmbH,
Plankstadt, Germany
Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June
2022
POM
720 BRU12060915NP Drapolene Cream Cetrimide 0.2%w/w; Benzalkonium
Chloride Solution 0.02%w/w
(equiv. to Benzalkonium Chloride
0.01%w/w)
GlaxoSmithKline Pharmacuetical
SA, Poznan, Poland
Kingston Beverage &
Creamery Sdn Bhd
30 June 2017 till 29 June
2022
GSL (55g)
721 BRU12060916P Rhewlin Gel 1%w/w Diclofenac Diethylamine equiv. to
Diclofenac Sodium 1%w/w
Beacons Pharmaceutical Pte Ltd,
Singapore
Hongkiat Trading & Company 30 June 2017 till 29 June
2022
GSL
722 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mg Pfizer Ireland Pharmacueticals,
Kildare, Republic of Ireland
Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June
2022
POM
723 BRU12070918P Beclomet Nasal Aqua
50mcg/dose Nasal Spray
Beclomethasone dipropionate
50mcg/dose
Orion Corporation, Kuopio,
Finland
Hongkiat Trading & Company 30 July 2017 till 29 July 2022 POM
724 BRU12070920NP Panadol® Biconvex Film-
coated Tablet 500mg
Paracetamol 500mg Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 July 2017 till 29 July 2022 P (50's, 3 x 10's &
15 x 10's)725 BRU12070921NP ENO Ginger Fruit Salt Sodium Bicarbonate Coarse 1.462g
(34.002%w/w); Sodium
Bicarbonate Fine 0.487g
(11.316%w/w); Citric Acid
Anhydrous 1.834g (42.640%w/w);
Sodium Carbonate Anhydrous
0.425g (9.892%w/w)
Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 July 2017 till 29 July 2022 GSL
726 BRU12070922NP ENO Fruit Salt Sodium Bicarbonate Coarse 1.489g
(34.63%w/w); Sodium Bicarbonate
Fine 0.496 (11.54%w/w); Citric
Acid Anhydrous 1.873g
(43.58%w/w); Sodium Carbonate
Anhydrous 0.43g (10.00%w/w)
Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 July 2017 till 29 July 2022 GSL
727 BRU12070923P Coversyl Plus 10mg/2.5mg
Tablet
Perindopril arginine 10mg (equiv.
to 6.79mg perindopril);
Indapamide 2.5mg
Servier (Ireland) Industries Ltd,
Ireland
Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM
728 BRU12070924P RotarixTM oral Suspension Human rotavirus RIX4414 strain,
not less than 106.0 CCID50
GlaxoSmithKline Biological SA,
Belgium
Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM
BDMCA/RMP/0319 Page 53 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
729 BRU12070925P CutivateTM Cream Fluticasone propionate
(micronised) 0.05%w/w
Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM
730 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/w GP Genzech Produktions GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 GSL
731 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1%
w/w
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 July 2017 till 29 July 2022 POM
732 BRU12070928P Sevoflurane Inhalation
Anaesthetic Liquid 100%
Sevoflurane 100% (1ml/ml) Baxter Healthcare Corporation,
Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM
733 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mg Pfizer Ireland Pharmaceuticals,
Kildare, Republic of Ireland
Zuellig Pharma (B) Sdn Bhd 29 August 2017 till 28
August 2022
POM
734 BRU12090933P Xarelto® Film-coated Tablet
10mg
Rivaroxaban 10mg Bayer Pharma AG, Leverkusen,
Germany
Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26
September 2022
POM
735 BRU12090937P Telfast 6mg/ml Oral
Suspension
Fexofenadine Hydrochloride
6mg/ml
Sanofi-Aventis Farmceutica Ltd,
Vila Areiao Suzano-SP-Brasil
Medipharm Sdn Bhd 27 September 2017 till 26
September 2022
POM
736 BRU12090938P Glucophage® XR 750mg
Extended Release Tablet
Metformin HCl 750mg Merck KGaA, Germany; Merck
Sante SAS, Semoy, France
Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26
September 2022
POM
737 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mg Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26
September 2022
POM
738 BRU12100940NP Dermoplex Calamine Cream Calamine (Fine) 4.00%; Zinc Oxide
3.00% w/w
Upha Pharmaceutical Mfg (M) Sdn
Bhd
Hongkiat Trading & Company 31 October 2018 till 30
October 2023
GSL
739 BRU12100941P;
BRU12100941PS2FragminTM Solution for
Injection 5,000IU (anti-
Xa)/0.2ml
Dalteparin Sodium 5,000IU (anti-
Xa)/0.2ml
Vetter Pharma-Fertigung GmbH &
Co., Germany; Pfizer
Manufacturing Belgium NV, Puurs,
Belgium (S2)
Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30
October 2022
POM
740 BRU12100942P Prostin E2TM Vaginal Tablet
3mg
Dinoprostone 3mg Sanico N.V., Turnhout, Belgium Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30
October 2022
POM
741 BRU12100943NP Dianeal Low Calcium
(2.5mEq/L) Peritoneal Dialysis
Solution with 2.5% Dextrose
Dextrose 2.5g; Sodium Chloride
538mg; Sodium Lactate 448mg;
Calcium Chloride dihydrate
18.3mg; Magnesium Chloride
Hexhydrate 5.08mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 31 October 2017 till 30
October 2022
POM
742 BRU12100944NP Potassium Chloride Tablet
600mg (Slow release)
Potassium Chloride 600mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 31 October 2017 till 30
October 2022
P (500's)
743 BRU12100945NP Anucare Suppositories Zinc Oxide 300mg; Balsam Peru
50mg; Benzyl Benzoate 33mg
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 31 October 2017 till 30
October 2022
GSL
BDMCA/RMP/0319 Page 54 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
744 BRU12100947P Illiadin Nasal Decongestant
Solution 0.01%
Oxymetazoline Hydrochloride
0.01%
Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30
October 2022
P
745 BRU12100948P Renvela (Sevelamer
Carbonate) Tablet 800mg
Sevelamer Carbonate 800mg Genzyme Ireland Limited, Ireland Medipharm Sdn Bhd 31 October 2017 till 30
October 2022
POM
746 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mg Pfizer Manufacturing Deutschland
GmbH, Freiburg, Germany
Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30
October 2022
POM
747 BRU12100950P QvarTM 100 Inhaler Beclomethasone dipropionate
100mcg per inhalation
3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30
October 2021
POM
748 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, Ireland Medipharm Sdn Bhd 31 October 2017 till 30
October 2021
POM
749 BRU12110953P;
BRU12110953PS2FragminTM Solution for
Injection 2,500IU (anti-
Xa)/0.2ml, Single dose syringe
Dalteparin Sodium 2,500IU (anti-
Xa)/0.2ml
Vetter Pharma-Fertigung GmbH &
Co., Germany; Pfizer
Manufacturing Belgium NV, Puurs,
Belgium (S2)
Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
750 BRU12110954P Efexor XR 150mg Capsule Venlafaxine (as Hydrochloride)
150mg
Pfizer Ireland Pharmaceuticals,
Kildare, Republic of Ireland
Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
751 BRU12110955P Eprex® 4000 Prefilled Syringe
4000IU/0.4ml
Epoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
752 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
753 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 27 November 2017 till 26
November 2022
GSL
754 BRU12110957PS1;
BRU12110957PS2
Actrapid® 100IU/ml Solution
for Injection
Insulin Human (rDNA) 100iu/ml Novo Nordisk A/S, Denmark (S1);
Novo Nordisk Production SAS,
France (S2)
Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
755 BRU12110958P Tretinon Cream 0.05% Tretinoin (Retinoic acid) 0.5mg/g Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
756 BRU12110959P Eprex® 2000 Prefilled Syringe
2000IU/0.5ml
Epoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
757 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mg Les Laboratories Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
GSL
758 BRU12110962P Tenol-100 Atenolol 100mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 27 November 2017 till 26
November 2022
POM
BDMCA/RMP/0319 Page 55 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
759 BRU12110963NP Polysilic III Suspension Per 5ml contains Dried Aluminium
Hydroxide Gel 400mg; Magnesium
Trisilicate light 400mg;
Simethicone 30mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 27 November 2017 till 26
November 2022
GSL (200ml);
GSL (3.8L)
760 BRU12110964P Exjade 125mg Dispersible
Tablets
Deferasirox 125mg Novartis Pharmas Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
761 BRU12110965P Exjade 500mg Dispersible
Tablets
Deferasirox 500mg Novartis Pharmas Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
762 BRU12110966P Dhamotil Tablets Diphenoxylate HCl BP 2.5mg;
Atropine Sulphate 0.025mg
Drug Houses of Australia Pte Ltd.,
Singapore
G & H Trading Company 27 November 2017 till 26
November 2022
POM
763 BRU12120967P CervarixTM Vaccine (Prefilled
Syringe)
1 dose (0.5ml) contains: Human
Papillomavirus type 16 L1 protein
20mcg; Human Papillomavirus type
18 L1 protein 20mcg; 3-O-desacyl-
4'-monophosphoryl lipid A (MPL)
50mcg; adsorbed on aluminium
hydroxide, hydrated (Al(OH)3)
0.5mcg Al3+
GlaxoSmithKine Biologicals S.A.,
Rixensart, Belgium
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
764 BRU12120968NP Dianeal Low Calcium
(2.5mEq/L) Peritoneal Dialysis
Sodium with 4.25% Dextrose
Per 100ml contains Calcium
Chloride 18.3mg; Dextrose hydrous
4.25g; Magnesium Chloride
5.08mg; Sodium Chloride 538mg;
Sdoium Lactate 448mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 27 December 2017 till 26
December 2022
POM
765 BRU12120969NP ENO Orange Each 4.3g contains Citric Acid
Anhydrous 1.851g; Sodium
Bicarbonate Coarse 1.478g;
Sodium Bicarbonate Fine 0.492;
Sodium Carbonate Anhydrous
0.43g
Sterling Drug (Malaya) Sdn Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
27 December 2017 till 26
December 2022
GSL
766 BRU12120970P Clementin Film Coated Tablet
625mg
Amoxicillin (as Trihydrate) 500mg;
Clavulanic Acid (as Potassium Salt)
125mg
Yung Shin Pharmaceutical Ind. Co.
Ltd., Taichung, Taiwan
Asterix United (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
767 BRU12120971P Survanta® Beractant
Intratracheal Suspension
Beractant (as phospholipids)
25mg/ml
AbbVie Inc., USA Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
768 BRU12120972P Humira Solution for Injection
40mg/0.8ml
Adalimumab 40mg/0.8ml Vetter-Pharma-Fertigung GmbH &
Co., KG, Ravensburg, Germany
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
BDMCA/RMP/0319 Page 56 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
769 BRU12120973P ZyprexaTM Tablet 10mg Olanzapine 10mg Lilly del Caribe Inc, Puerto Rico,
USA & Lilly S.A., Madrid, Spain
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
770 BRU12120974P SutentTM Hard Capsules
12.5mg
Sunitinib 12.5mg (as Malate) Pfizer Italia S.r.l., Ascoli Piceno,
Italy
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
771 BRU12120975PS1 ;
BRU12120975PS2
Stelara Solution for Injection
in pre-filled syringe
45mg/0.5ml
Ustekinumab 45mg/0.5ml Baxter Pharmaceutical Solutions
LLC, Blommington, United States
(S1);
Cilag AG, Hochstrassse 201, 8200
Schaffhausen. Switzerland (S2)
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
772 BRU12120976P Viagra 50mg Tablet Sildenafil 50mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
773 BRU12120977P Viagra 100mg Tablet Sildenafil 100mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
774 BRU12120978P Aerrane (Isoflurane USP)
Inhalation Liquid
Isoflurane USP 100% Baxter Healthcare Corporation,
Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
775 BRU12120979P Kogenate FS for Injection
250IU/vial
Antihaemophilic Factor
(recombinant) sucrose formulated
250IU
Bayer Healthcare LLC., United
States
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
776 BRU12120980NP Potcit Mixture Per 5ml contains Potassium Citrate
1g; Citric acid anhydrous 200mg
Beacons Pharmaceutical Pte Ltd.,
Singapore
Hongkiat Trading & Company 27 December 2017 till 26
December 2022
P (3.8L)
777 BRU12120981P Garbose Tablet 100mg Acarbose 100mg Y.S.P Industries (M) Sdn Bhd.,
Selangor Darul Ehsan, Malaysia
Asterix United (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
778 BRU13010982P KombiglyzeTM XR Tablet
5/1000mg
Saxagliptin HCl 5mg (as anhydrous
5.58mg); Metformin Hydrochloride
1000mg
AstraZeneca Pharmaceuticals LP,
USA
Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
779 BRU13010983P KombiglyzeTM XR Tablet
5/500mg
Saxagliptin HCl 5mg (as anhydrous
5.58mg); Metformin Hydrochloride
500mg
AstraZeneca Pharmaceuticals LP,
USA
Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
780 BRU13010984P KombiglyzeTM XR Tablet
2.5/1000mg
Saxagliptin HCl 2.5mg (as
anhydrous 2.79mg); Metformin
Hydrochloride 1000mg
AstraZeneca Pharmaceuticals LP,
USA
Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
781 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mg Recordati Industria Chimica &
Farmaceutica S.p.A., Milan, Italy
Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
BDMCA/RMP/0319 Page 57 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
782 BRU13010987P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
783 BRU13010988P Co-Trimexazole Suspension Per 5ml - Sulphamethoxazole BP
200mg; Trimethoprim 40mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & CO 26 January 2018 till 25
January 2023
POM
784 BRU13010991P Humulin 30/70 Injection
100iu/ml (vial)
Human insulin* 100IU/mL
*In the proportion of 30% Soluble
Insulin to 70% Isophane Insulin
Eli Lilly and Co., USA Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
785 BRU13010993P FML® Liquifilm Sterile
Opthalmic Solution 0.1%
Fluorometholone 0.1%w/v Allergan Pharmaceuticals Ireland,
Ireland
Medipharm Sdn Bhd 26 January 2018 till 25
January 2023
POM
786 BRU13010995P Daivonex® Ointment Calcipotriol 50mcg/g (0.005% w/w) LEO Laboratories Ltd (LEO
Pharma), Ireland
Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
787 BRU13010996P Seretide Evohaler 25/125mcg Per actuation - Fluticasone
propionate 125mcg; Salmetarol
25mcg (as xinafoate)
Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
788 BRU13010997P Glucophage® Tablet 850mg Metformin HCl 850mg
(~Metformin 662.9mg)
Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
789 BRU13010998PS1;
BRU13010998PS2Revlimid®Capsules 5mg Lenalidomide 5mg Penn Pharmaceutical Services
Limited, UK (S1) & Celgene
International Sarl, Switzerland (S2)
Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
790 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 January 2018 till 25
January 2023
GSL
791 BRU13011000P Inpanol Tablets 10mg Propranolol BP 10mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 26 January 2018 till 25
January 2020
POM
792 BRU13011003P Nimotop Infusion Solution
0.02%
Nimodipine 0.01g/50ml Bayer Schering Pharma AG,
Leverkeusen, Germany
Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
793 BRU13011005P Zyprexa 5mg Tablet Olanzapine 5mg Lilly del Caribe Inc., Puerto Rico,
USA & Lilly, S.A., Spain
Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
794 BRU13021006P Canesten GYN 6 day 6-Day-
Therapy
Clotrimazole 100mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
P
795 BRU13021008P Prevenar 13 Suspension for
Injection
Per 0.5ml - Pneumococcal
Polysaccharide Serotype 1, 3, 4, 5,
6A, 7F, 9V, 14, 18C, 19A, 19F, 23F -
2.2mcg; Pneumococcal
Polysaccharide Serotype 6B -
4.4mcg
Pfizer Ireland Pharmaceuticals,
Dublin, Ireland
Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
POM
BDMCA/RMP/0319 Page 58 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
796 BRU13021009P Hemabate Sterile Solution
250mcg/ml
Carboprost (as tromethamine)
250mcg/ml
Pharmacia & Upjohn Company
LLC, USA
Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
POM
797 BRU13021011P Extraneal Peritoneal Dialysis
Solution 75g/L
Per 100ml: Icodextrin 7.5g; Sodium
Chloride 538mg; Sodium Lactate
448mg; Calcium Chloride 25.7mg;
Magnesium Chloride 5.08mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 26 February 2018 till 25
February 2023
POM
798 BRU13021012P Afinitor Tablet 10mg Everolimus 10mg Novartis Pharma Stein AG, Stein,
Switzerland
Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
POM
799 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, Malaysia G & H Trading Company 26 February 2018 till 25
February 2023
POM
800 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w) S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
POM
801 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mg Beacons Pharmaceutical Pte Ltd,
Singapore
Hongkiat Trading & Co 26 February 2018 till 25
February 2023
POM
802 BRU13021017P Hydrogen Peroxide Solution
6%
Hydrogen Peroxide 6% w/v
(equivalent to 20 volumes of
oxygen)
Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Co 26 February 2018 till 25
February 2023
GSL
803 BRU13021018P Inpanol Tablets 40mg Propranolol BP 40mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 26 February 2018 till 25
February 2020
POM
804 BRU13021019P Stilamin 3000 for Injection
3mg/ampoule
Somatostatin (as acetate) 3mg Merck Serono SA, Aubonne,
Switzerland
G&H Trading Company 26 February 2018 till 25
February 2023
POM
805 BRU13021020P Loradine Syrup 1mg/ml Loratadine 1mg/ml Y.S.P Industries (M) Sdn Bhd,
Selangor Darul Ehsan, Malaysia
Asterix United (B) Sdn Bhd 26 February 2018 till 25
February 2023
P
806 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 26 February 2018 till 25
February 2023
GSL
807 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2ml Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan, ROC
Asterix United (B) Sdn Bhd 26 February 2018 till 25
February 2023
POM
808 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mg Noripharma Sdn Bhd, Selangor
Darul Ehsan, Malaysia
K-Seri Pharma Sdn Bhd 26 February 2018 till 25
February 2023
POM
809 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE)
0.625mg/g
Pfizer Canada Inc., Canada Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
POM
810 BRU13021026P Kaletra Film-coated Tablet
200mg/50mg
Lopinavir 200mg; Ritonavir 50mg AbbVie Deutschland GmbH & Co.
KG, Germany
Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
POM
BDMCA/RMP/0319 Page 59 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
811 BRU13021027P Sustanon 250 Per 1ml - Testosterone decanoate
100mg; Testosterone
phenylpropionate 60mg;
Testosterone isocaproate 60mg;
Testosterone propionate 30mg
[Equivalent to Testosterone
176mg/ml]
Merck Sharp & Dohme, the
Netherlands
Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
POM
812 BRU13021028P Holoxan for Injection Ifosfamide 1g Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
POM
813 BRU13031029NP Panadol Extend Tablet Paracetamol 665mg GlaxoSmithKline Consumer
Healthcare Australia Pty Ltd.,
Australia
Kingston Beverage &
Creamery Sdn Bhd
28 March 2018 till 27 March
2023
P (8 x 6's)
814 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/w Encube Ethicals Private Ltd, India Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March
2023
GSL
815 BRU13031033PS1;
BRU13031033PS2
Metoclopramide Tablet 10mg Metoclopramide HCl BP
(equivalent to Metoclopramide HCl
anhydrous 10mg)
Drug House of Australia Pte Ltd,
Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 28 March 2018 till 27 March
2020
POM
816 BRU13031034P Loperamil Tablet 2mg Loperamide 2mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 28 March 2018 till 27 March
2020
POM
817 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Co 28 March 2018 till 27 March
2023
POM
818 BRU13031036P Dhacort Cream 1%w/w Hydrocortisone acetate BP
(micronised) 1% w/w
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 28 March 2018 till 27 March
2020
POM
819 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mg Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 28 March 2018 till 27 March
2023
POM
820 BRU13031038P Solcoseryl Dental Adhesive
Paste
Per g - Solcoseryl CMC 2.125mg;
Polidocanol 10mg
Legacy Pharmaceuticals
Switzreland GmbH, Switzerland
Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March
2023
POM
821 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 28 March 2018 till 27 March
2023
POM
822 BRU13031040P Intril SR 1.5mg Tablets Indapamide 1.5mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 28 March 2018 till 27 March
2023
POM
823 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2018 till 27 March
2023
POM
824 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2018 till 27 March
2023
POM
BDMCA/RMP/0319 Page 60 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
825 BRU13031045P Recormon Pre-filled Syringe
2000IU/0.3ml
Erythropoetin Beta 2,000iu/0.3ml Roche Diagnostics GmbH,
Germany
MediPharm Sdn Bhd 28 March 2018 till 27 March
2023
POM
826 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH & Co. KG., Germany Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March
2023
POM
827 BRU13031047P Recormon Pre-filled Syringe
4000IU/0.3ml
Erythropoetin Beta 4,000iu/0.3ml Roche Diagnostics GmbH,
Germany
MediPharm Sdn Bhd 28 March 2018 till 27 March
2023
POM
828 BRU13031049P Saizen for Injection
3.33mg/vial
Somatropin 3.33mg (10 IU) Merck Serono S.A., Switzerland G & H Trading Company 28 March 2018 till 27 March
2023
POM
829 BRU13031050P;
BRU13031050PS2
Isentress 400mg Tablet Raltegravir 400mg (as potassium
434.4mg)
MSD Technology Singapore Pte
Ltd., Singapore; MSD International
GmbH, Ireland (S2)
Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March
2023
POM
830 BRU13041051P Taxotere 80mg/4ml
Concentrate for Solution for
Infusion
Docetaxel trihydrate 80mg/4ml Sanofi-Aventis Deutschland
GmbH, Germany
Medipharm Sdn Bhd 30 April 2018 till 29 April
2023
POM
831 BRU13041052P Fosamax Plus Tablet
70mg/5600IU
Alendronic Acid 70mg (as Sodium
91.37mg); Colecalciferol 140mcg
(5,600IU)
MSD Frosst Iberica, S.A., Madrid,
Spain
Zuellig Pharma (B) Sdn Bhd 30 April 2018 till 29 April
2023
POM
832 BRU13041053P Glucovance Tablet
500mg/2.5mg
Metformin HCl 500mg,
Glibenclamide 2.5mg
Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd 30 April 2018 till 29 April
2023
POM
833 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mg Y.S.P Industries (M) Sdn Bhd
Malaysia
K-Seri Pharma Sdn Bhd 30 April 2018 till 29 April
2023
POM
834 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/w Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 April 2018 till 29 April
2023
GSL
835 BRU13041058P Pegasys Pre-filled Syringe
180mcg/0.5ml
Peginterferon alfa-2a
180mcg/0.5ml
F Hoffman-La Roche Ltd,
Switzerland; ; F Hoffman-La Roche
Ltd, Betriebsstandort Kaiseraugst
(Parenterals), Switzerland
Hongkiat Trading & Co 30 April 2018 till 29 April
2023
POM
836 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mg Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 April 2018 till 29 April
2023
POM
837 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Delpharm Milano S.r.I., Via
Carnevale 1, 20090, Segrate
(Milano), Italy
Hongkiat Trading & Co 30 April 2018 till 29 April
2023
POM
838 BRU13041061NP Venofer® Solution for
Injection 100mg/5ml
Iron (III) [as Iron (III)-hydroxide
sucrose complex] 100mg/5ml
IDT Biologika GmbH, Germany;
BIPSO GmbH, Germany
Hongkiat Trading & Co 30 April 2018 till 29 April
2023
POM
BDMCA/RMP/0319 Page 61 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
839 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3%
w/w
Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 April 2018 till 29 April
2023
GSL
840 BRU13041063P Apuzin tablet 25mg Captopril 25mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 April 2018 till 29 April
2023
POM
841 BRU13041064P Lezpain film-coated tablet
135mg
Mebeverine HCl 135mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 April 2018 till 29 April
2023
POM
842 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, Germany
[Repacker: Beacons
Pharmaceuticals Pte Ltd., 21 Chin
Bee Avenue, Singapore]
Hongkiat Trading & Co 30 April 2018 till 29 April
2023
GSL
843 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/v Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 April 2018 till 29 April
2023
GSL
844 BRU13061069P Votrient™ Film-coated tablets
200mg
Pazopanib (as hydrochloride)
200mg
Glaxo Operations UK Ltd,
Hertfordshire, UK
Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June
2023
POM
845 BRU13061070PS1;
BRU13061070PS2;
BRU13061070PS3
NovoMix® 30 FlexPen®
Suspension for Injection 100
U/ml
1ml contains 100u of Soluble
Insulin aspart 30% and Protamine-
crystallised Insulin aspart 70%
Novo Nordisk Producao
Farmaceutica do Brasil Ltda., Brazil
(S1); Novo Nordisk A/S, Bagsværd,
Denmark (S2); Novo Nordisk
Production SAS, France (S3)
Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June
2023
POM
846 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mg Abbott Biologicals B.V., The
Netherlands
Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June
2023
POM
847 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 04 June 2018 till 03 June
2023
POM
848 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, France Hongkiat Trading & Co 04 June 2018 till 03 June
2023
POM
849 BRU13061075P Minison Tablet 1mg Prazosin 1mg (as HCl 1.095mg) Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 04 June 2018 till 03 June
2023
POM
850 BRU13061076P Xeloda™ Tablets 500mg Capecatibine 500mg Productos Roche S.A. de C.V,
Mexico
Hongkiat Trading & Co 04 June 2018 till 03 June
2023
POM
851 BRU13061077P Chloramphenicol Eye
Ointment
Chloramphenicol 10mg/g KRKA d.d., Slovenia K-Seri Pharma Sdn Bhd 04 June 2013 till 03 June
2018
POM
852 BRU13061078NP Zentel Tablet 200mg Albendazole 200mg Tianjin SKF Labs Ltd, Tianjin, China Kingston Beverage &
Creamery Sdn Bhd
04 June 2018 till 03 June
2023
GSL (2's)
853 BRU13061079NP Maltofer® Syrup Iron (III) [as Iron (III)-hydroxide-
polymaltose complex] 10mg/ml
Vifor S.A., Switzerland Medipharm Sdn Bhd 04 June 2018 till 03 June
2023
GSL
854 BRU13061080P Noriday® Tablet Norethisterone 0.35mg Piramal Healthcare UK Limited,
United Kingdom
Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June
2023
POM
BDMCA/RMP/0319 Page 62 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
855 BRU13061081P Keppra 250mg Film-coated
Tablet
Levetiracetam 250mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June
2023
POM
856 BRU13061082P Keppra 500mg Film-coated
Tablet
Levetiracetam 500mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June
2023
POM
857 BRU13061083PS1,
BRU13061083PS2,BR
U13061083PS3,
BRU13061083PS4
Avastin Concentrate For
Solution For Infusion
400mg/16ml
Bevacizumab 400mg/16ml Genentech Inc., USA (S1); F-
Hoffman-La Roche Ltd, Basel,
Switzerland (S2); Roche
Diagnostics GmbH, Manheim,
Germany (S3); F Hoffmann-La
Roche Ltd, Kaiseraugst,
Switzerland (S4)
Hongkiat Trading & Co 04 June 2018 till 03 June
2023
POM
858 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mg Productos Roche S.A. de C.V,
Mexico
Hongkiat Trading & Co 04 June 2018 till 03 June
2023
POM
859 BRU13061085P Uripax Film-coated Tablet
200mg
Flavoxate HCl 200mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 04 June 2018 till 03 June
2023
POM
860 BRU13061087P Elonva Solution for Injection
150mcg/0.5ml
Corifollitrophin alfa 150mcg/0.5ml Vetter Pharma-Fertigung GmbH &
Co. KG, Germany
Zuellig Pharma (B) Sdn Bhd 27 June 2018 till 26 June
2023
POM
861 BRU13061088P Maxitrol Eye Ointment Per g: Neomycin Sulfate 3,500 IU;
Polymyxin B Sulfate 6,000IU;
Dexamethasone 0.1%
S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 27 June 2018 till 26 June
2023
POM
862 BRU13061090NP Ciproxol (Ciprofloxacin) 0.2%
w/v Intravenous Infusion BP
Ciprofloxacin 0.2% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2018 till 26 June
2023
POM
863 BRU13061091NP Infusol® W Intravenous
Infusion BP
Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2018 till 26 June
2023
GSL
864 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml
(0.1%)
EVER Pharma Jena GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 27 June 2018 till 26 June
2023
POM
865 BRU13061093P Invoril tablets 10mg Enalapril maleate 10mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 27 June 2018 till 26 June
2019
POM
866 BRU13061094P Pharmaniaga Simvastatin
tablet 10mg
Simvastatin 10mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 27 June 2018 till 26 June
2023
POM
867 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 27 June 2013 till 26 June
2018
POM
868 BRU13061096P Invoril tablets 20mg Enalapril maleate 20mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 27 June 2013 till 26 June
2018
POM
869 BRU13061097P Seldron Cleaning Lotion Selenium Sulphide USP 2.5% w/v ICM Pharma Pte Ltd, Singapore Mc Quipp Technisell
Marketing Sdn Bhd
27 June 2018 till 26 June
2023
p
BDMCA/RMP/0319 Page 63 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
870 BRU13071098NP Cortal for Children Tablet Acetaminophen (Paracetamol)
80mg
Sterling Drug (Malaya) Sdn Bhd,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 July 2013 till 29 July 2018 P
12 x 12's (144's)
871 BRU13071099P Champix 1mg film-coated
tablet
Varenicline Tartrate 1mg Pfizer Manufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM
872 BRU13071100P Iodosorb Ointment Cardexomar Iodine (eq. to Iodine
0.9%)
Perstorp Speciality Chemicals,
Sweden
Mc Quipp Technisell
Marketing Sdn Bhd
30 July 2018 till 29 July 2023 P
873 BRU13071101P Glucophage XR 500mg
Extended Release Tablet
Metformin HCl 500mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM
874 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mg Schering-Plough (Singapore) Pte
Ltd, Singapore
Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
875 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 July 2018 till 29 July 2023 POM
876 BRU13071104P Gonal-F Powder and Solvent
for Solution for Injection 75IU
(5.5mcg)/ vial
Follitrophin Alfa 75 IU ( 5.5mcg) Merck Serono S.p.A., Bari (MSB),
Italy; Merck Serono S.A. (MSA),
Swizerland
G & H Trading Company 30 July 2018 till 29 July 2023 POM
877 BRU13071108PS1;
BRU13071108PS2
Revlimid® Capsules 25mg Lenalidomide 25mg Penn Pharmaceutical Services
Limited, UK (S1) & Celgene
International Sarl, Switzerland (S2)
Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM
878 BRU13071109PS1;
BRU13071109PS2
Revlimid® Capsules 15mg Lenalidomide 15mg Penn Pharmaceutical Services
Limited, UK (S1) & Celgene
International Sarl, Switzerland (S2)
Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM
879 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate
8.3mg/g
Legacy Pharmaceuticals
Switzreland GmbH, Switzerland
Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM
880 BRU13071111P Micosten-H Cream Miconazole Nitrate 2%;
Hydrocortisone 1%
Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 30 July 2018 till 29 July 2023 POM
881 BRU13071114P Sandimmun Neoral Capsule
25mg
Ciclosporin A 25mg Catalent Germany Eberbach
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM
882 BRU13081115P Champix 0.5mg & 1mg Tablet Varenicline Tartrate 0.5mg &
Varenicline Tartrate 1mg
Pfizer Manufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26
August 2023
POM
883 BRU13081116P Daktarin Oral Gel 2% Miconzaole 2% Janssen Pharmaceutical NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26
August 2023
P
884 BRU13081120P Enbrel® 25mg solution for
injection in pre-filled syringe
Etanercept 25mg/0.5ml Pfizer Ireland Pharmaceuticals,
Ireland
Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26
August 2023
POM
BDMCA/RMP/0319 Page 64 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
885 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26
August 2023
POM
886 BRU13081123P Minazol Powder 2% Miconazole Nitrate 2% w/w Biosis Pharmaceuticals Sdn Bhd.,
Malaysia
K-Seri Pharma Sdn Bhd 27 August 2018 till 26
August 2023
P
887 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine)
5,000IU/ml
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 August 2018 till 26
August 2023
POM
888 BRU13081125P Pharmaniaga Pyrazinamide
Tablet 500mg
Pyrazinamide 500mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 27 August 2018 till 26
August 2023
POM
889 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, Malaysia G & H Trading Company 27 August 2018 till 26
August 2023
POM
890 BRU13081128P Maxitrol Eye Drops Per 1ml - Dexamethasone 0.1%;
Neomycin Sulphate 3,500IU;
Polymyxin B Sulphate 6,000 IU
S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26
August 2023
POM
891 BRU13091130P Erbitux® 5mg/ml Solution for
Infusion
Cetuximab 5mg/ml Boehringer Ingelheim, Germany &
Merck KGaA, Germany (1
Artwork)
Zuellig Pharma (B) Sdn Bhd 28 September 2018 till 27
September 2023
POM
892 BRU13091132NP Beafort Syrup Each 5ml contains: Thiamine HCl
5mg; Riboflavin 2.5mg; Pyridoxine
HCl 2mg; Cyanocobalamin 5mcg;
Nicotinamide 20mg; Calcium
Panthothenate 1.5mg
Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 28 September 2013 till 27
September 2018
GSL
893 BRU13091133P Clexane 4000/0.4ml Anti XA
Pre-filled Syringe
Enoxaprin sodium 4,000 anti-Xa
IU/0.4ml equivalent to 40mg/0.4ml
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 28 September 2018 till 27
September 2023
POM
894 BRU13091134P Pantaprazole Winthrop 40mg
Tablet
Pantoprazole (as sodium
Sesquihydate) 40mg
Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 28 September 2018 till 27
September 2023
POM
895 BRU13091135P Iodosorb Powder Cadexomer 99.1% w/w, with
Iodine 0.9%w/w
Perstorp Speciality Chemicals AB,
Sweden
Mc Quipp Technisell
Marketing Sdn Bhd
28 September 2018 till 27
September 2023
P
896 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mg Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 28 September 2018 till 27
September 2023
POM
897 BRU13091138P Clexane 6000/0.6ml Anti-Xa
IU Pre-filled Syringe
Enoxaprin sodium 6,000 anti-Xa
IU/0.6ml equivalent to 60mg/0.6ml
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 28 September 2018 till 27
September 2023
POM
898 BRU13091140P Camazol Tablet 5mg Carbimazole 5mg Xepa-Soul Pattinson (M) Sdn Bhd
Malaysia
Hongkiat Trading & Co 28 September 2018 till 27
September 2023
POM
899 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2ml Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 28 September 2018 till 27
September 2023
POM
BDMCA/RMP/0319 Page 65 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
900 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mg Pahang Pharmacy Sdn Bhd,
Malaysia
K-Seri Pharma Sdn Bhd 28 September 2018 till 27
September 2023
GSL
901 BRU13091143P VelcadeTM 3.5mg for Injection Bortezomib 3.5mg Pierre Fabree Medicament
Productio (PFMP), France & BSP
Pharmaceuticals S.p.A. (BSP),
Latina, Italy - (1 artwork)
Zuellig Pharma (B) Sdn Bhd 28 September 2018 till 27
September 2023
POM
902 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 28 September 2018 till 27
September 2023
POM
903 BRU13091145NP A-Bite Cream Crotamiton 10%w/w HOE Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 28 September 2018 till 27
September 2023
GSL
904 BRU13091146P Tipidin Tablet 250mg Ticolopidine HCl BP 250mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 28 September 2013 till 27
September 2018
POM
905 BRU13101149P Erycin Film Coated Tablet
250mg
Erythromycin (as stearate) 250mg Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 31 October 2018 till 30
October 2023
POM
906 BRU13101151NP ENO Fruit Salt Lemon Per 4.3g - Sodium Bicarbonate
Coarse 1.468g (34.16%w/w);
Sodium Bicarbonate Fine 0.489g
(11.39%w/w); Citric Acid
Anhydrous 1.853g (43.10%w/w);
Sodium Carbonate Anhydrous
0.43g (10.0%w/w)
Sterling Drug (Malaya) Sdn Bhd,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
31 October 2018 till 30
October 2023
GSL
907 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mg GlaxoSmithKline Manufacturing
S.p.A., Parma, Italy
Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30
October 2023
POM
908 BRU13101153P Clexane 2000 anti-Xa IU/0.2ml
(Pre-filled Syringe for
Injection)
Enoxaparin Sodium 2,000 anti-Xa
IU/0.2ml
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 31 October 2018 till 30
October 2023
POM
909 BRU13101154P Axcel Mefenamic Acid
Suspension
Mefenamic Acid 125mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 31 October 2018 till 30
October 2023
POM
910 BRU13101155P Ovidrel Solution for Injection
250mcg/0.5ml in Pre-filled
Syringe
Choriogonadotropin alfa
250mcg/0.5ml
Merck Serono S.p.A., Italy &
Merck Serono S.A., Switzerland
G & H Trading Company 31 October 2018 till 30
October 2023
POM
911 BRU13101156P Sandimmun Neoral Capsule
100mg
Ciclosporin 100mg Catalent Germany Eberbach
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30
October 2023
POM
BDMCA/RMP/0319 Page 66 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
912 BRU13101158P Endoxan Tablet 50mg Cyclophosphamide anhydrous (as
monohydrate) 50mg
Prasfarma S.L.,
Manlleu/Barcelona, Spain; Haupt
Pharma Amareg GmBH, Germany
Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30
October 2023
POM
913 BRU13101159P CEF-4® Injection 500mg Ceftazidime (as pentahydrate)
500mg
Siam Bheasach Co. Ltd., Bangkok,
Thailand
K-Seri Pharma Sdn Bhd 31 October 2018 till 30
October 2023
POM
914 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mg Pfizer Ireland Pharmaceuticals,
Kildare, Ireland
Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30
October 2023
POM
915 BRU13101161PS1;
BRU13101161PS2
Revlimid® Capsules 10mg Lenalidomide 10mg Penn Pharmaceutical Services
Limited, UK (S1) & Celgene
International Sarl, Switzerland (S2)
Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30
October 2023
POM
916 BRU13101162P Pharmaniaga Cephalexin
Suspension 125mg
Cephalexin (as anhydrous)
125mg/5ml
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 31 October 2018 till 30
October 2023
POM
917 BRU13101164P Isopto Homatropine 2%
Sterile Ophthalmic Solution (
Homatropine Hydrobromide 2%
(20.0mg/ml)
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 31 October 2013 till 30
October 2018
POM
918 BRU13101165NP Lactacyd Feminine Hygiene
Liquid
Per 100ml - Lactic Acid 1g;
Atomised Lactoserum (spray dried)
0.93g
Sanofi Synthelabo Vietnam, Ho Chi
Minh City, Viet Nam
Medipharm Sdn Bhd 31 October 2013 till 30
October 2018
GSL
919 BRU13121167P Copastin Film Coated Tablets
10mg
Cloperastine Hydrochloride 10mg Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 02 December 2018 till 01
December 2023
P
920 BRU13121168P Ucort Cream Per g – Urea 100mg;
Hydrocortisone acetate 10mg
Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 02 December 2018 till 01
December 2023
POM
921 BRU13121169P Pradaxa® Hard Capsules
150mg
Dabigatran etexilate 150mg (as
mesilate 172.95g)
Boehringer Ingelheim Pharma
GmbH &Co, Ingelheim am Rhein,
Germany
Hongkiat Trading & Co 02 December 2018 till 01
December 2023
POM
922 BRU13121170P Pradaxa® Hard Capsules
110mg
Dabigatran etexilate 110mg (as
mesilate 126.83g)
Boehringer Ingelheim Pharma
GmbH & Co., KG, Germany
Hongkiat Trading & Co 02 December 2018 till 01
December 2023
POM
923 BRU13121172NP Dianeal Low Calcium
(2.5mEq/L) Peritoneal Dialysis
Solution with 1.5% Dextrose
Each 100ml contains: Calcium
Choloride 18.3mg; Dextrose
hydrous 1.5g; Magnesium Chloride
5.08mg; Sodium Chloride 538mg;
Sodium Lactate 448mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 02 December 2018 till 01
December 2023
POM
924 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 02 December 2018 till 01
December 2023
POM
BDMCA/RMP/0319 Page 67 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
925 BRU13121177P Cyclogyl® 1% Sterile
Ophthalmic Solution
Cyclopentolate Hydrochloride 1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 December 2018 till 01
December 2023
POM
926 BRU13121178P Betawin Tablet 50mg Metoprolol Tartrate 50mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co 02 December 2013 till 01
December 2018
POM
927 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29
December 2023
POM
928 BRU13121180P Glucovance Tablet
500mg/5mg
Metformin HCl 500mg;
Glibenclamide 5mg
Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29
December 2023
POM
929 BRU13121181P Priorix-Tetra Powder and
Diluent for Solution for
Injection
Composition of Priorix™ per dose
(0.5ml): Live attenuated measles
virus (Schwarz strain) ≥103.0 CCID50,
Live attenuated mumps virus
(RIT4385 strain) ≥103.7 CCID50, Live
attenuated rubella virus (Wistar RA
27/3 strain) ≥103.0 CCID50, Live
attenuated Varicella Virus (OKA
strain) ≥103.3 PFU
Glaxosmithkline Biologicals S.A.,
Belgium
Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29
December 2023
POM
930 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mg GlaxoSmithKline Manufacturing
S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29
December 2023
POM
931 BRU13121183P Anarex Tablets Paracetamol 450mg; Orphenadrine
citrate 35mg
Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 December 2013 till 29
December 2018
POM
932 BRU13121184P Atarax Film-Coated Tablet
25mg
Hydroxyzine Hydrochloride 25mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29
December 2023
POM
933 BRU13121187NP 10% Glucose Intravenous
Infusion B.P.
Glucose monohydrate (as equiv. to
anhydrous glucose) 10%
B Braun Industries Sdn Bhd,
Malaysia
Hongkiat Trading & Co 30 December 2018 till 29
December 2023
POM
934 BRU13121189P Heparinised Saline Injection
10iu/ml (5ml)
Heparin Sodium (Bovine Mucosa)
10i.u./ml
B Braun Medical Industries Sdn
Bhd, Malaysia
Hongkiat Trading & Co 30 December 2018 till 29
December 2023
POM
935 BRU13121190P Rescuvolin Tablet 15mg Calcium Folinate (equiv. to Folinic
Acid) 15mg
Teva Pharmaceutical Works Pte
Ltd Co., Debrecen Site, Hungary
K-Seri Pharma Sdn Bhd 30 December 2013 till 29
December 2018
POM
936 BRU13121192NP Nutriflex Lipid Peri Emulsion
for Infusion
1 unit consists of Amino Acid
Solution; Glucose Solution; Lipid
Emulsion (For Detailed
Formulation referred to Dossier)
B Braun Industries Sdn Bhd,
Malaysia
Hongkiat Trading & Co 30 December 2018 till 29
December 2023
POM
937 BRU14011193PS1 Alimta 500mg Powder for
Solution for Infusion
Pemetrexed (as Pemetrexed
disodium) 500mg/vial
Eli Lilly and Company, USA (S1); Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27
January 2024
POM
BDMCA/RMP/0319 Page 68 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
938 BRU14011194P Gemzar 1G Powder for
Solution for Infusion
Gemcitabine hydrochloride
equivalent to 1000mg gemcitabine
Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
939 BRU14011196P Largo Tablets 100mg Chlorpromazine HCl 100mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 28 January 2014 till 27
January 2019
POM
940 BRU14011197NP Axcel Eviline Forte
Suspension
Each 5ml contains: Magnesium
Hydroxide 400mg, Aluminium
Hydroxide 400mg and Simethicone
40mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd, Malaysia 28 January 2019 till 27
January 2024
GSL
941 BRU14011198NP Bepanthen® First Aid Cream Dexpanthenol 5%w/w;
Chlorhexidine hydrochloride 0.5%
w/w
GP Grenzach Produktions GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27
January 2024
GSL
942 BRU14011199NP Dextrose 5% and Sodium
Chloride 0.9% Injection USP
Dextrose 5%; Sodium Chloride
0.9%
Baxter Healthcare Corporation,
USA
Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27
January 2024
GSL
943 BRU14011200NP Macgel® Tablet Magnesium Hydroxide 200mg;
Aluminium Hydroxide Gel Dried
200mg; Dimethylpolysiloxane
25mg
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 28 January 2019 till 27
January 2024
GSL
944 BRU14011203P Betaserc 24mg Tablet Betahistine dihydrochloride 24mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
945 BRU14011204P Humalog Mix50 100 units/ml
Kwikpen
Insulin Lispro * 100U/ml
(equivalent to 3.5mg) * in the
proportion of 50% insulin lispro
solution and 50% insulin lispro
protamine suspension (rDNA
origin)
Lilly France S.A.S., France (S1)
(repacker - Eli Lilly And Company,
USA
Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27
January 2024
POM
946 BRU14011205NP Panamol Tablet 500mg Paracetamol 500mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 28 January 2014 till 27
January 2019
GSL (100 x 10's)
947 BRU14011206P Seretide™ Evohaler™
25/50mcg
Fluticasone propionate 50mcg;
Salmeterol (as xinafoate) 25mcg
Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27
January 2024
POM
948 BRU14011207PS1;
BRU14011207PS2
Tobrex® Eye Drops Solution Tobramycin 0.3% (3mg/ml) S.A. Alcon-Couvreur N.V., Belgium
(S1); Alcon Singapore
Manufacturing Pte Ltd, Singapore
(S2)
Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27
January 2024
POM
BDMCA/RMP/0319 Page 69 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
949 BRU14011208P PNEUMOVAX 23 Pneumococcal Polysaccharide
Danish Types 1,2,3,4,5,6B,
7F,8,9N,9V, 10A, 11A, 12F, 14, 15B,
17F, 18C, 19A, 19F, 20, 22F, 23F,
33F. Each 0.5ml dose contains
25µg of each polysaccharide type
Merck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27
January 2024
POM
950 BRU14011209P NEUPOGEN PRE-FILLED
SYRINGE 30MU/0.5ML
Filgrastim 30mu/0.5ml F.Hoffmann-La Roche Ltd,
Kaiseraugst
Switzerland
Medipharm Sdn Bhd 28 January 2014 till 27
January 2019
POM
951 BRU14011211NPS1;
BRU14011211NPS2
Tears Naturale II Eye Drops
Solution
Dextran 70 0.1% (1mg/ml);
Hypromellose 0.3% (3mg/ml)
S.A. Alcon-Couvreur N.V., Belgium
(S1); Alcon Singapore
Manufacturing Pte Ltd, Singapore
(S2)
Hongkiat Trading & Company 28 January 2019 till 27
January 2024
GSL
952 BRU14011212P Axcel Chlorpheniramine-4
Syrup
Chlorpheniramine Maleate
4mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd, Malaysia 28 January 2019 till 27
January 2024
P
953 BRU14011213P Imojev Japanese Encephalitis
vaccine (live, attenuated) MD
Live, attenuated, recombinant
Japanese Encephalitis virus 4.0 -
5.8 log PFU*/dose (0.5ml) *Plaque
Forming Unit
Government Pharmaceutical
Organization - Meriux Biological
Products Co., Ltd., Thailand
Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27
January 2024
POM
954 BRU14021215P Havrix 1440 Vaccine Inactivated Hepatitis A virus
antigen (HAV), HM175 strain 1440
ELISA Units (EL.U.)/ml
GlaxoSmithKline Biologicals SA,
Rixensart Belgium (Manufacturer
of finished products);
GlaxoSmithKline Biologicals S.A.,
Wavre Belgium (Additional facility
for formulation)
Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
955 BRU14021216P Co-Plavix® 75/100 film-coated
tablets
Clopidogrel (as hydrogen sulphate)
75mg; Acetylsalicylic acid 100mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 27 February 2019 till 26
February 2024
POM
956 BRU14021217P VotrientTM Film-coated tablets
400mg
Pazopanib (as hydrochloride)
400mg
Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
957 BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen-Cilag, Val de Reuil, France Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
BDMCA/RMP/0319 Page 70 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
958 BRU14021219PS1;
BRU14021219PS2;
BRU14021219PS3
Novorapid® Flexpen®
100IU/ml
1ml of solution contains 100U
insulin aspart (r-DNA) (equivalent
to 3.5mg)
Novo Nordisk Producao
Farmaceutica do Brasil Ltda., Brazil
(S1); Novo Nordisk A/S, Denmark
(S2); Novo Nordisk Production
SAS, France (S3)
Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
959 BRU14021220P Omelon Enteric
Microencapsulated capsule
20mg
Omeprazole 20mg Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
960 BRU14021223P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
50mg/0.5ml
0.5ml of solution contains
Paliperidone (as palmitate 78mg)
50mg
Janssen Pharmaceutica NV,
Belgium;
Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
961 BRU14021224P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
75mg/0.75ml
0.75ml of solution contains
Paliperidone (as palmitate 117mg)
75mg
Janssen Pharmaceutica NV,
Belgium;
Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
962 BRU14021225P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
100mg/1.0ml
1.0ml of solution contains
Paliperidone (as palmitate 156mg)
100mg
Janssen Pharmaceutica NV,
Belgium;
Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
963 BRU14021227P LumiganTM (Bitamoprost
Ophthalmic Solution) 0.03%
Bimatoprost 0.03% w/v Allergan Sales, LLC, USA Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
BDMCA/RMP/0319 Page 71 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
964 BRU14021229P NovoSeven® Powder and
Solvent for Solution for
Injection 2mg
Eptacog Alfa (Activated) 2mg/vial
(corresponds to 100 KIU/vial),
1mg/ml after reconstitution.
1 KIU equals 1000 IU (International
Units)
eptacog alfa (activated) is
recombinant coagulation factor
VIIa (rFVIIa) with a molecular mass
of approximately 50,000 Dalton
produced in baby hamster kidney
cells (BHK Cells) by recombinant
DNA technology.
Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
965 BRU14021230NP Axcel Eviline Tablet Aluminium Hydroxide 200mg,
Magnesium Hydroxide 200mg,
Simethicone 20mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 27 February 2019 till 26
February 2024
GSL
966 BRU14021231P Axcel Loratadine syrup Loratadine 5mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 27 February 2019 till 26
February 2024
P
967 BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride)
30mg
Lilly del Caribe, Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
968 BRU14021233P TykerbTM tablets 250mg Lapatinib 250mg (as ditosylate
monohydrate)
Glaxo Operations UK Limited
(Trading as Glaxo Wellcome
Operations), UK [Repacker: Glaxo
Wellcome S.A., Burgos, Spain
Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
969 BRU14021234P Axcel Mefenamic Acid
Capsules
Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 27 February 2019 till 26
February 2024
POM
970 BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
971 BRU14021236NP Lactated Ringer’s Injection
USP
Sodium Chloride 6g/L; Sodium
Lactate 3.1g/L; Potassium Chloride
0.3g/L; Calcium Chloride 0.2g/L
Baxter Healthcare Corporation,
USA
Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
GSL
972 BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH & Co. KG, Germany Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
BDMCA/RMP/0319 Page 72 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
973 BRU14021238NP Axcel Dicyclomine-S Syrup Per 5mL: Dicyclomine
hydrochloride 5mg and
Simethicone 50mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 27 February 2019 till 26
February 2024
GSL
974 BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin
(Recombinant DNA) 100IU/ml
Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
975 BRU14021240NP 5% Dextrose and 0.45%
Sodium Chloride Injection,
USP
Dextrose 5%; Sodium Chloride
0.45%
Baxter Healthcare Corporation,
USA
Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
GSL
976 BRU14021241P Giona Easyhaler 200mcg/dose
Inhalation Powder
Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading & Co 27 February 2014 till 26
February 2019
POM
977 BRU14021242P Amoxicillin Capsule 500mg Amoxicillin Trihydrate 500mg Yung Shin Pharmaceutical Ind. Co.,
Taiwan
Asterix United (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
978 BRU14021243NP Neurobion tablet Thiamine disulfide 100mg;
Pyridoxine hydroxide 200mg &
Cyanocobalamin 200mcg
Merck KGaA & Co, Austria Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
GSL
979 BRU14021244P Omeprazole for Injection
(Lyophilised) 40mg/vial
Omeprazole 40mg/vial Gland Pharma Limited, India K-Seri Pharma Sdn Bhd 27 February 2019 till 26
February 2024
POM
980 BRU14021245P Keppra Concentrate for
solution for (infusion) /
intravenous
Levetiracetam 500mg/5ml Patheon Italia S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
981 BRU14021246P Imojev Japanese Encephalitis
Vaccine (live, attenuated)
Live, attenuated, recombinant
Japanese Encephalitis virus 4.0 -
5.8 log PFU*/ dose (0.5ml) *
Plaque Forming Unit
Government Pharmaceutical
organization-Meriux Biological
Products Co., Ltd., Thailand
Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26
February 2024
POM
982 BRU14021247P Pradaxa® Hard Capsules 75mg Dabigatran etexilate 75mg (as
mesilate 86.48mg)
Boehringer Ingelheim Pharma
GmbH & Co., KG, Germany
Hongkiat Trading & Co 27 February 2019 till 26
February 2024
POM
983 BRU14021248P Axcel Flemin Expectorant Diphenhydramine HCl 12.5mg/5ml;
Ammonium Chloride 130mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 27 February 2019 till 26
February 2024
POM
984 BRU14031249P Tygacil 50mg Lyophilised
Powder for Intravenous
Infusion
Tigecycline 50mg Wyeth Lederle S.r.L, Italy Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
985 BRU14031250PS1;BR
U14031250PS2
BRU14031250PS3
Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml
(equivalent to 14.2mg
Novo Nordisk A/S, Bagsværd,
Denmark (S1); Novo Nordisk
Producao Farmaceutica do Brasil
Ltda., Brazil (S2); Novo Nordisk
Production SAS, France (S3)
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
BDMCA/RMP/0319 Page 73 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
986 BRU14031251P Stalevo 75/18.75/200mg Film-
coated Tablet
Levodopa 75mg; Carbidopa
18.75mg; Entacapone 200mg
Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
987 BRU14031252P Stalevo 200/50/200mg Film-
coated Tablet
Levodopa 200mg; Carbidopa
50mg; Entacapone 200mg
Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
988 BRU14031253P Humulin N Injection 100IU/mL Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
989 BRU14031256P Gonal-F 300IU/0.5ml solution
for injection in a pre-filled pen
Each pen (0.5ml) contains 300IU
follitropin alfa (eq. to 22
micrograms)
Merck Serono S.p.A, Italy G&H Trading Company 27 March 2019 till 26 March
2024
POM
990 BRU14031257P Gonal-F 900IU/1.5ml Solution
for Injection in a pre-filled pen
Each pen (1.5ml) contains 900IU
follitropin alfa (eq. to 66
micrograms). Each ml of solution
contains 600IU follitropin alfa
(equivalent to 44 micrograms)
Merck Serono S.p.A, Italy G&H Trading Company 27 March 2019 till 26 March
2024
POM
991 BRU14031258P Volibris 5mg Film-coated
Tablet
Ambrisentan 5mg Patheon Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
992 BRU14031259P Volibris 10mg Film-coated
Tablet
Ambrisentan 10mg Patheon Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
993 BRU14031261P Prograf Capsule 1mg Tacrolimus 1mg Astellas Ireland Ltd, Ireland MediPharm Sdn Bhd 27 March 2019 till 26 March
2024
POM
994 BRU14031262P Loperamil Syrup 1mg/5ml Loperamide HCl 1mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
POM
995 BRU14031263P;
BRU14031263PS2
Patanol® Eye Drops, Solution
0.1%
Olopatadine (as HCl) 0.1% S.A. Alcon-Couvreur N.V., Belgium;
Alcon Singapore Manufacturing
Pte. Ltd., Singapore (S2)
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
996 BRU14031264PS1;
BRU14031264PS2
Travatan® Eye Drops
40mcg/ml
Travoprost 40mcg/ml S.A. Alcon-Couvreur N.V., Belgium
(S1); Alcon Singapore
Manufacturing Pte Ltd, Singapore
(S2)
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
997 BRU14031265P;
BRU14031265PS2
Chlorpheniramine tablet 4mg Chlorpheniramine Maleate 4mg Drug Houses of Australia Pte Ltd,
Singapore; PT Actavis Indonesia,
Indonesia (S2)
G&H Trading Company 27 March 2014 till 26 March
2019
POM
998 BRU14031267P Motilium Suspension 1mg/ml Domperidone 1mg/ml Janssen Pharmaceutica NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
999 BRU14031268P Elonva Solution for Injection
100mcg/0.5ml
Corifollitropin alfa 100mcg/0.5ml Vetter Pharma-Fertigung GmbH &
Co. KG, Germany
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
BDMCA/RMP/0319 Page 74 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1000 BRU14031269P Menveo Powder & Solution
for Solution for Injection
One dose (0.5ml of the
reconstituted vaccine) contains:
Originally contained in the powder:
Meninggococcal group A
oligosaccharide 10micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein 16.7 to
33.3 micrograms)
Originally contained in the
solution: Meninggococcal group C
oligosaccharide 5micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein…..7.1
to 12.5 micrograms);
Meninggococcal group W135
oligosaccharide 5micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein 3.3 to
8.3 micrograms); Meninggococcal
group Y oligosaccharide
5micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein….5.6
to 10.0. micrograms)
Novartis Vaccines and Diagnostics
GmbH, Germany; Novartis
Vaccines and Diagnostics S.r.I, Italy
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
1001 BRU14031270P Enbrel® 50mg solution for
Injection in a pre-filled syringe
Etanercept 50.0mg/1.0ml Pfizer Ireland Pharmaceuticals,
Ireland
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
1002 BRU14031272P Seretide Evohaler dose-
counter 25/250mcg
Salmeterol 25mcg (as the
xinafoate) and Fluticasone
Propionate 250mcg
Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
BDMCA/RMP/0319 Page 75 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1003 BRU14031273PS1;
BRU14031273PS2
Galvus Met 50/500mg Film-
coated Tablet
Vildagliptin 50mg; Metformin HCl
500mg(corresponding to 390mg
Metformin)
Novartis Pharma Stein AG,
Switzerland (S1); Novartis Pharma
Produktions GmbH, Germany (S2)
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
1004 BRU14031274PS1;
BRU14031274PS2
Galvus Met 50/1000mg Film-
coated Tablet
Vildagliptin 50mg; Metformin HCl
1000mg(corresponding to 780mg
Metformin)
Novartis Pharma Stein AG,
Switzerland (S1); Novartis Pharma
Produktions GmbH, Germany (S2)
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
1005 BRU14031275PS1;
BRU14031275PS2
Galvus Met 50/850mg Film-
coated Tablet
Vildagliptin 50mg; Metformin HCl
850mg(corresponding to 660mg
Metformin)
Novartis Pharma Stein AG,
Switzerland (S1); Novartis Pharma
Produktions GmbH, Germany (S2)
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
1006 BRU14031276P Galvus 50mg Tablet Vildagliptin 50mg Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
1007 BRU14031278P Conazole Cream Miconazole nitrate 2.0% w/w;
Betamethasone 0.1% w/w (as
valerate); Gentamicin (as sulphate)
0.1% w/w
Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
POM
1008 BRU14031279NP Axcel Paracetamol-250
Suspension (Orange)
Paracetamol 250mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 27 March 2019 till 26 March
2024
GSL (60 mL & 100
mL)1009 BRU14031280P Lamictal Dispersible/Chewable
Tablet 25mg
Lamotrigine 25mg GlaxoSmithKline Pharmaceutical
SA, Poland
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
1010 BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine
Phosphate 9mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 27 March 2014 till 26 March
2019
POM
1011 BRU14031282P Voren Injection ‘Yung Shin’
(Diclofenac)
Diclofenac Sodium 75mg/3ml Yung Shin Pharmaceutical Ind,
Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
1012 BRU14031283P Dhasolone Syrup 3mg/5ml Prednisolone 3mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
POM
1013 BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing Belgium NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March
2024
POM
1014 BRU14041285P Giona Easyhaler®
100mcg/dose Inhalation
Powder
Budesonide 100mcg/dose Orion Corporation, Finland Hongkiat Trading & Company 26 April 2014 till 25 April
2019
POM
1015 BRU14041286P Axcel Nasatab Tablet Paracetamol 500mg;
Chlorpheniramine Maleate 4mg;
Pseudoephedrine HCl 60mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 26 April 2019 till 25 April
2024
P (10 x 10's)
BDMCA/RMP/0319 Page 76 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1016 BRU14041287P XareltoTM Film-coated tablet
15mg
Rivaroxaban 15mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM (14's x 2; 7's
x 1; 14's x 1)
1017 BRU14041288P XareltoTM Film-coated tablet
20mg
Rivaroxaban 20mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM
(14’s x 2
14’s x 1)1018 BRU14041289P Metformin 500 Tablet 500mg Metformin HCl BP 500mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1019 BRU14041291NP Sodium Chloride Injection USP
0.9% in Mini-Bag Plus
Container
Sodium Chloride 0.9% Baxter Healthcare Corporation,
Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
GSL
1020 BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate
213.8mg (eq. to anhydrous
Cyclophosphamide 200mg)
Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM
1021 BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM
1022 BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM
1023 BRU14041296P Shincort IM Injection “Yung
Shin” 5ml vial
Triamcinolone acetonide 40mg/ml Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM
1024 BRU14041297PS1;
BRU14041297PS2
DuoTrav Eye Drops, Solution Travoprost 40mcg/ml; Timolol
5mg/ml (as timolol maleate)
S.A. Alcon-Couvreur N.V., Belgium
(S1); Alcon Singapore
Manufacturing Pte Ltd, Singapore
(S2)
Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM
1025 BRU14041299P Hypernol 100 Tablets 100mg Atenolol 100mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1026 BRU14041300P Hypernol Tablets 50mg Atenolol 50mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1027 BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride,
monohydrate) 150mg
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM
1028 BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride,
monohydrate) 200mg
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM
1029 BRU14041304NP Infusol NSD5 Sodium Chloride 9g/L; Dextrose
anhydrous 50g/L
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2014 till 25 April
2019
POM
1030 BRU14041305NP Lactul Solution 670mg/ml Lactulose 670mg/ml Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 April 2019 till 25 April
2024
GSL
1031 BRU14041306P Kytril for Infusion 1mg/ml Granisetron 1mg (equivalent to
Granisetron hydrochloride 1.12mg)
Cenexi SAS, France Hongkiat Trading & Company 26 April 2014 till 25 April
2019
POM
BDMCA/RMP/0319 Page 77 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1032 BRU14041307P Alimta 100mg Powder for
Solution for Infusion
Pemetrexed (as Pemetrexed
disodium) 100mg/vial
Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
POM
1033 BRU14041308P Decofam Cough Syrup Per 5mL contains Ephedrine HCl
4mg; Guaiphenesin 50mg &
Ammonium Chloride 80mg
Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
P
1034 BRU14041309NP RinsCap W (Sterile Water for
Injection BP)
Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2014 till 25 April
2019
GSL (500ml)
1035 BRU14041310PS1;
BRU14041310PS2
Famotin Tablet 40mg Famotidine 40mg Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis
Indonesia,
Jakarta,Indonesia (S2)
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1036 BRU14041311P Paradrine Tablet Paracetamol 500mg;
Pseudoephedrine HCl BP 20mg;
Chlorpheniramine Maleate BP 2mg
Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
P (10 x 10 x 10's)
1037 BRU14041313P Ibuprofen Suspension
20mg/ml
Ibuprofen 20mg/ml Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 April 2014 till 25 April
2019
P
1038 BRU14041314NP;
BRU14041314NPS2
Sodium Chloride Injection
0.9%, USP
Sodium Chloride 0.9% Baxter Healthcare Corporation,
USA (S1); Baxter Healthcare
Philippines Inc., Laguna,
Phillippines (S2)
Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April
2024
GSL
1039 BRU14041315P Rivadem 3mg Capsule Rivastigmine (as hydrogen tartrate)
3mg
Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 26 April 2014 till 25 April
2019
POM
1040 BRU14041316P Rivadem 1.5mg Capsule Rivastigmine (as hydrogen tartrate)
1.5mg
Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 26 April 2014 till 25 April
2019
POM
1041 BRU14041317P Rozidal Tablet 1mg Risperidone 1mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1042 BRU14071319PS1 &
BRU14071319PS2
Mixtard® 30 100IU/ml Insulin Human, rDNA ( as Isophane
Insulin) 70%, Insulin Human, rDNA
(as soluble insulin) 30%
Novo Nordisk A/S, Bagsvaerd,
Denmark (S1); Novo Nordisk
Productions SAS, France (S2)
Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1043 BRU14071320P Protopic Ointment 0.03% Tacrolimus 0.3mg/g (0.03%) Astellas Pharma Tech Co., Ltd.,
Japan
Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1044 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5ml Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1045 BRU14071322P Nootropil 1200mg Tablet Piracetam 1200mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1046 BRU14071323P Nootropil 800mg Tablet Piracetam 800mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
BDMCA/RMP/0319 Page 78 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1047 BRU14071324P Luvox® Film-coated Tablets
50mg
Fluvoxamine maleate 50mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1048 BRU14071325P Luvox® Film-coated Tablets
100mg
Fluvoxamine maleate 100mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1049 BRU14071326P TobraDex® Eye Ointment Tobramycin 0.3%, Dexamethasone
0.1%
S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1050 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH & Co. KG., Germany Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1051 BRU14071329NP Axcel Papain Tablet Papain Pure equiv. to proteolytic
enzymes from carica papaya
10,000 USP Units
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 02 July 2019 till 01 July 2024 GSL
1052 BRU14071330P Humalog® KwikPenTM
100units/mL
Insulin Lispro 100units/ml Lilly France S.A.S., France (S1
(repacker - Eli Lilly And Company,
USA)
Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1053 BRU14071331P Shincort IM Injection "Yung
Shin" 40mg/ml ampoules
Triamcinolone acetonide 40mg Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1054 BRU14071332P Emend IV Powder For Solution
for Infusion 150mg
Fosaprepitant 150mg (as
fosaprepitant dimeglumine)
DSM Pharmaceuticals Inc., USA Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1055 BRU14071333PS1;
BRU14071333PS2
Zytiga Tablets 250mg Abiraterone acetate 250mg Patheon Inc. Canada (S1); Patheon
S.A.S. (Patheon-France), France
(S2)
Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1056 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate) Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 02 July 2019 till 01 July 2024 POM
1057 BRU14071335P Anlodin Tablet 5mg Amlodipine 5mg (as Besylate
6.93mg)
Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1058 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w 3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1059 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mg Pfizer Ireland Pharmaceuticals,
Ireland
Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1060 BRU14071338PS1;
BRU14071338PS2
Regro Lotion 5% Minoxidil USP 5% w/v Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 02 July 2014 till 01 July 2019 P
BDMCA/RMP/0319 Page 79 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1061 BRU14071339PS1;
BRU14071339PS2
Regro Lotion 3% Minoxidil USP 3% w/v Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 02 July 2014 till 01 July 2019 P
1062 BRU14071340NP Dequalinium Lozenges Dequalinium Chloride 0.25mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 02 July 2014 till 01 July 2019 GSL
1063 BRU14071341P DHA-Ketozole Tablet 200mg Ketoconazole 200mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1064 BRU14071342P Axcel Ibuprofen Paediatric
Syrup
Ibuprofen 100mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 02 July 2019 till 01 July 2024 P
1065 BRU14071343P Pharynx Lozenges Cetylpyridinium Chloride 1.50mg,
Benzocaine 3.33mg
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 02 July 2014 till 01 July 2019 P
1066 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1067 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1068 BRU14071346P Hydrocort Cream Hydrocortisone acetate 10mg/g
(1% w/w)
Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1069 BRU14071347P Invoril Tablet 5mg Enalapril Maleate 5mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1070 BRU14071348P Atropine Sulphate 1mg/1ml
Injection
Atropine Sulphate 1mg/ml Pharmaniaga Lifesciences Sdn
Bhd, Malaysia
G & H Trading Company 02 July 2019 till 01 July 2024 POM
1071 BRU14071349P;
BRU14071349PS2
Dhacodine Syrup 15mg/5ml Pholocodine 15mg/5ml Drug Houses of Australia Private
Limited, Singapore; ICM PHARMA
PTE LTD, Singapore (S2)
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1072 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 02 July 2019 till 01 July 2024 POM
1073 BRU14071353P Salbutamol Injection
0.5mg/ml
Salbutamol Sulphate 0.5mg/ml
(equivalent to salbutamol base)
Yung Shin Pharmaceutical Ind., Co.
Ltd., Taichong, Taiwan
Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1074 BRU14071354PS1;
BRU14071354PS2
Glipizide Tablet 5mg Glipizide 5mg Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1075 BRU14071355P Axcel Dexchlorpheniramine
Tablet
Dexchlorpheniramine 2mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 02 July 2019 till 01 July 2024 POM
BDMCA/RMP/0319 Page 80 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1076 BRU14071356P;
BRU14071356PS2
Phenexpect CD Syrup Per 5 ml - Diphenhydramine HCl BP
12.5mg; Ammonium Chloride BP
135mg; Codeine Phosphate BP
5.7mg
Drug Houses of Australia Private
Limited, Singapore; ICM PHARMA
PTE LTD, Singapore (S2)
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1077 BRU14071357P Quinine Sulphate Tablet
300mg
Quinine Sulphate BP 300mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1078 BRU14071358NP 20% Glucose Intravenous
Infusion BP
Glucose (as monohydrate) 20% B. Braun Medical Industries Sdn
Bhd Malaysia
Hongkiat Trading & Co 02 July 2019 till 01 July 2024 POM
1079 BRU14071359P Pharmaniaga Spironolactone
Tablet 25mg
Spironolactone 25mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 02 July 2019 till 01 July 2024 POM
1080 BRU14071360P Maxidex Sterile Opthalmic
Suspension
Dexamethasone 0.1% ( 1mg/ml) S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1081 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP
1000IU/ml
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 02 July 2014 till 01 July 2019 POM
1082 BRU14071362P Alphagan Ophthalmic Solution
0.2%
Brimonidine tartrate (anhydrous
basis) 2mg/ml
Allergan Pharmaceuticals Ireland,
Ireland
Medipharm Sdn Bhd 02 July 2014 till 01 July 2019 POM
1083 BRU14071363P Dormicum Injection
15mg/3ml
Midazolam 15mg/3ml Cenexi SAS, France Hongkiat Trading & Company 02 July 2019 till 01 July 2024 POM
1084 BRU14071365NP 0.18% sodium Chloride and
4.3% Glucose Intravenous
Infusion
0.18% Sodium Chloride 0.18%;
Glucose 4.3%
B.Braun Medical Industries Sdn
Bhd., Malaysia
Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1085 BRU14071367P Invega Sustenna Prolonged
Release Suspension for IM
Injection 150mg/1.5ml
Paliperidone 150mg/1.5ml (as
palmitate 234mg)
Janssen Pharmaceutical NV,
Belgium;
Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM
1086 BRU14071368P Yondelis® Powder for Injection
1mg/vial
Trabectedin 0.05mg/ml Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1087 BRU14071369P Trajenta film-coated tablet
5mg
Linagliptin 5mg Boehringer Ingelhein Roxane Inc.,
USA
Hongkiat Trading & Company 24 July 2019 till 23 July 2024 POM
1088 BRU14071370P Novoseven® 1mg Powder and
Solvent for Solution for
Injection
Eptacog alfa (activated) 1mg/ml
(corresponds to 50KIU/vial) -
1mg/ml after reconstitution
Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1089 BRU14071372PS1 &
BRU14071372PS2
Invega® Extended-Release
Tablet 9mg
Paliperidone 9mg [Layer 1 - 2.7mg;
Layer 2 - 6.3mg]
ALZA Corporation, USA (S1);
Janssen Cilag Manufacturing L.L.C.,
Puerto Rico (S2)
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1090 BRU14071373PS1 &
BRU14071373PS2
Invega® Extended-Release
Tablet 3mg
Paliperidone 3mg [Layer 1 - 0.9mg;
Layer 2 - 2.1mg]
ALZA Corporation, USA (S1);
Janssen Cilag Manufacturing L.L.C.,
Puerto Rico (S2)
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
BDMCA/RMP/0319 Page 81 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1091 BRU14071374PS1 &
BRU14071374PS2
Invega® Extended-Release
Tablet 6mg
Paliperidone 6mg [Layer 1 - 1.8mg;
Layer 2 - 4.2mg]
ALZA Corporation, USA (S1);
Janssen Cilag Manufacturing L.L.C.,
Puerto Rico (S2)
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1092 BRU14071375P Lucentis 10mg/ml Solution for
Injection
Ranibizumab 10mg/ml Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1093 BRU14071376P Onbrez Breezhaler 150mcg
Inhalation Powder, Hard
Capsule
Indacterol 150mcg (as maleate
194mcg)
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1094 BRU14071377P Onebrez Breezhaler 300mcg
Inhalation Powder Hard
Capsule
Indacterol 300mcg (as maleate
389mcg)
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1095 BRU14071378P Requip PD 24hr Prolong
Release Tablet 2mg
Ropinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1096 BRU14071379P Difflam Anti-Inflammatory
Lozenges (with Anti-bacterial)
Benzydamine Hydrochloride 3mg;
Cetylpyridinium Chloride 1.33mg
Unique Pharmaceutical
Laboratories, India
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 GSL
1097 BRU14071380P Vfend Powder For Oral
Suspension 40mg/ml
Voriconazole 40mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1098 BRU14071381P Norditropin® Nordilet®
Solution for Injection
10mg/1.5ml
Somatropin (biosynthetic human
growth hormone) 10mg/1.5ml
Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1099 BRU14071382P Alphagan P Ophthalmic
Solution 0.15%
Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd 24 July 2019 till 23 July 2024 POM
1100 BRU14071383P Mapenem® IV Injection
500mg
Meropenem 500mg (as trihydrate) Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 24 July 2019 till 23 July 2024 POM
1101 BRU14071384P Curam Powder for oral
Suspension 312.5mg/5ml
Amoxycillin 250mg (as trihydrate);
Clavulanic Acid 62.5mg (as
potassium salt)
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1102 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1103 BRU14071386P Tussils 5 Lozenge 5mg Dextromethorphan Hydrobromide
5mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1104 BRU14071387P Kivexa Tablets 600mg/300mg Abacavir 600mg (as sulfate);
Lamivudine 300mg
GlaxoSmithKline Pharmaceuticals
S.A, Poland [Repacker: Glaxo
Wellcome, S.A., Spain]
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1105 BRU14071388P Lucrin® depot 3.75mg
Injection
Leuproprelin acetate 3.75mg Takeda Pharmaceutical Company
Limited, Japan
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
BDMCA/RMP/0319 Page 82 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1106 BRU14071389P Lucrin® depot 11.25mg
Injection
Leuproprelin acetate 11.25mg Takeda Pharmaceutical Company
Limited, Japan
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1107 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 24 July 2019 till 23 July 2024 POM
1108 BRU14071391P Lamictal Tablet 50mg Lamotrigine 50mg Glaxosmithkline Pharmaceuticals
SA, Poland
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1109 BRU14071392P Infasurf® (Calfactant)
Intratracheal Suspension
Per ml - Phospholipids 35mg
(including 26mg
phosphatidycholine of which 16mg
is disaturated phosphatidycholine)
and 0.7mg protein (incuding
0.26mg of SP-B0Calfactant [Calf
lung Surfactant Extract -CLSE]
ONY Biotech Inc., USA K-Seri Pharma 24 July 2019 till 23 July 2024 POM
1110 BRU14071393NP Kaolin & Pectin Mixture Per 5ml - Kaolin Light BP 1g; Pectin
50mg
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 24 July 2014 till 23 July 2019 P
1111 BRU14071394P Duodart 0.5mg/0.4mg
Capsules
Dutasteride 0.5mg; Tamsulosin
0.4mg
Catalent Germany Schorndorf
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1112 BRU14071395P Axcel Metronidazole-400
Tablet
Metronidazole 400mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 24 July 2019 till 23 July 2024 POM
1113 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1114 BRU14071397PS1 &
BRU14071397PS2 &
BRU14071397PS3
MABTHERA Concentrate for
Solution for Infusion
500mg/50ml
Rituximab 500mg/50ml Genetech Inc., USA (S1); F.
Hoffmann-LA Roche Ltd,
Switzerland (S2); and Roche
Diagnostics GmbH, Germany (S3)
MediPharm Sdn Bhd 24 July 2019 till 23 July 2024 POM
1115 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 24 July 2014 till 23 July 2019 POM
1116 BRU14071399PS1 &
BRU14071397PS2
Vigamox® Ophthalmic
Solution 0.5%
Moxifloxacin 0.5% (as
hydrochloride)
ALCON LABORATORIES, INC., USA
(S1)
Alcon Singapore Manufacturing
Pte. Ltd., Singapore (S2)
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1117 BRU14071400P Cementin Tablet 200mg Cimetidene 200mg Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 24 July 2014 till 23 July 2019 POM
BDMCA/RMP/0319 Page 83 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1118 BRU14071401PS1 &
BRU14071401PS2
Voltaren Emulgel 1% Diclofenac diethylamine
1.16g/100g (equivalent to 1g of
diclofenac sodium)
Novartis Pharma Produktions
GmbH, Germany (S1 for pack size
50g) & Novartis Consumer Health
SA, Switzerland (S2 for pack size
20g)
Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 GSL
1119 BRU14071402P Imexa Film-Coated Tablet
250mg
Azithromycin 250mg (as dihydrate) Xepa-Soul Pattinson (M) Sdn Bhd
Malaysia
Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM
1120 BRU14071403P Cymbalta Capsule 60mg Duloxetine (as hydrochloride)
60mg
Lilly del Caribe Inc, Puerto Rico Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1121 BRU14071404P Beanamine Expectorant Per 5ml - Diphenhydramine BP
10mg; Ammonium Chloride BP
120mg)
Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM
1122 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, Malaysia G & H Trading Company 24 July 2019 till 23 July 2024 POM
1123 BRU14071406P Dimenate Tablet 50mg Dimenhydrinate BP 50mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 24 July 2014 till 23 July 2019 POM (5 x 20 x
10's; 1000's)1124 BRU14071407P Dhatifen Tablet 1mg Ketotifen 1mg (as hydrogen
fumarate 1.38mg)
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 24 July 2014 till 23 July 2019 POM
1125 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1126 BRU14071409P Asumalife Syrup 1.38mg/5ml Per 5ml - Ketotifen 1mg (as
hydrogen fumarate 1.38mg)
Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1127 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mg Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1128 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as
Hydrochloride)
Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1129 BRU14071412NP Zoben Tablet 200mg Albendazole 200mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 24 July 2019 till 23 July 2024 P (10 x 10's)
1130 BRU14071413P Clamentin Injection 600mg Amoxycillin 500mg (as sodium);
Clavulanic Acid 0.1g (as
Clavulanate potassium)
Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1131 BRU14071414P Garbose Tablet 50mg Acarbose 50mg Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM
1132 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM
1133 BRU14081416PS1;
BRU14081416PS2
Sevorane Inhalation Liquid Sevoflurane 100%v/v Aesica Queensborough Ltd, UK
(S1); Abbvie S.R.L, Italy (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
BDMCA/RMP/0319 Page 84 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1134 BRU14081417PS1;
BRU14081417PS2
Emend Tri-Pack Capsule Each capsule either contains
Aprepitant 80mg or 125mg
Merck Sharp & Dohme Corp., USA
(S1); Alkermes Pharma Ireland
Limited, Ireland (S2)
Repackers:
1) Merck Sharp & Dohme
(Australia) Pty. Ltd., Australia.
(Primary and secondary packaging
and release)
2) PT. Merck Sharp Dohme
Pharma Tbk., Indonesia. (Primary
and secondary packaging and
release)
3) Contract repacker: Contract
Pharmaceutical Services of
Australia Pty Ltd., Australia.
(Primary and secondary
packaging)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1135 BRU14081418P Protopic Ointment 0.1% Tacrolimus (as Tacrolimus
monohydrate) 0.1%
Astellas Pharma Tech Co., Ltd.,
Japan
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1136 BRU14081419PS2 Exforge HCT 10/160/12.5mg
Film-coated tablet
Amlodipine 10mg (as besylate);
Valsartan 160mg;
Hydrochlorothiazide 12.5mg
Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1137 BRU14081420PS2 Exforge HCT 10/160/25mg
Film-coated tablet
Amlodipine 10mg (as besylate);
Valsartan 160mg;
Hydrochlorothiazide 25mg
Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1138 BRU14081421PS2 Exforge HCT 5/160/12.5mg
Film-coated tablet
Amlodipine 5mg (as besylate);
Valsartan 160mg;
Hydrochlorothiazide 12.5mg
Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1139 BRU14081422PS2 Exforge HCT 5/160/25mg Film-
coated tablet
Amlodipine 5mg (as besylate);
Valsartan 160mg;
Hydrochlorothiazide 25mg
Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1140 BRU14081423PS2 Exforge HCT 10/320/25mg
Film-coated tablet
Amlodipine 10mg (as besylate);
Valsartan 320mg;
Hydrochlorothiazide 25mg
Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1141 BRU14081424P Luveris for Injection 75IU/Vial
(Revised Formula)
Lutropin alfa 75IU (Recombinant
Human Lutenising Hormone)
Merck Serono SA., Switzerland G & H Trading Company 30 August 2019 till 29
August 2024
POM
1142 BRU14081425P Lipanthyl Penta 145 Film-
Coated tablet
Fenofibrate 145mg Recipharm Fontaine, France Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
BDMCA/RMP/0319 Page 85 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1143 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 August 2014 till 29
August 2019
POM
1144 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mcg GlaxoWellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1145 BRU14081428PS1
BRU14081428PS2JanumetTM Tablet
50mg/850mg
Sitagliptin 50mg (as phosphate);
Metformin HCl 850mg
Patheon Puerto Rico, Inc., Manati,
PR 00674, Puerto Rico (S1) &
Aesica Queensborough Limited,
UK (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1146 BRU14081429PS1
BRU14081429PS2JanumetTM Tablet
50mg/500mg
Sitagliptin 50mg (as phosphate);
Metformin HCl 500mg
Patheon Puerto Rico, Inc., Manati,
PR 00674, Puerto Rico (S1) &
Aesica Queensborough Limited,
UK (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1147 BRU14081430PS1
BRU14081430PS2JanumetTM Tablet
50mg/1000mg
Sitagliptin 50mg (as phosphate);
Metformin HCl 1000mg
Patheon Puerto Rico Inc., Manati,
Puerto Rico (S1) & Aesica
Queensborough Limited, UK (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1148 BRU14081431P Napan Capsules 250mg Mefenamic Acid 250mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 August 2014 till 29
August 2019
POM
1149 BRU14081432PS1 &
BRU14081432PS2 &
BRU14081432PS3
Mabthera Concentrate for
Solution for Infusion
100mg/10ml
Rituximab 100mg/10ml Genetech Inc., USA; F Hoffmann-
LA Roche Ltd, Switzerland; Roche
Diagnostics GmbH, Germany
MediPharm Sdn Bhd 30 August 2019 till 29
August 2024
POM
1150 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vial Pharmacia & Upjohn Company
LLC, USA
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1151 BRU14081434P Moxiclav 1G Tablet Amoxycillin 875mg (as sodium);
Clavulanic Acid 125mg (as
Clavulanate potassium)
Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 August 2019 till 29
August 2024
POM
1152 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1153 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2019 till 29
August 2024
POM
1154 BRU14081440P Naphcon-A Sterile Ophthalmic
Solution
Naphazoline Hydrochloride 0025%;
Pheniramine maleate 0.3%
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 August 2014 till 29
August 2019
P
1155 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mg Glaxosmithkline Pharmaceuticals
SA, Poland
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
BDMCA/RMP/0319 Page 86 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1156 BRU14081442P Axcel Loratadine Tablet Loratadine 10mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 August 2019 till 29
August 2024
P
1157 BRU14081443NP Neuroxel Tablet Thiamine Mononitrate 100mg;
Pyridoxine HCl 200mg;
Cynocobalamin 200mcg
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 August 2014 till 29
August 2019
P
1158 BRU14081444P Rhiniramine SR Tablet 6mg Dexhlorpheniramine Maleate 6mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 August 2014 till 29
August 2019
POM
1159 BRU14081445P Buventhol Easyhaler
100mcg/dose inhalation
powder
Salbutamol sulphate
100mcg/actuation (delivered dose
90mcg/actuation)
Orion Corporation, Finland Hongkiat Trading & Co 30 August 2014 till 29
August 2019
POM
1160 BRU14081446P Buventhol Easyhaler
200mcg/dose inhalation
powder
Salbutamol sulphate
300mcg/actuation (delivered dose
180mcg/actuation)
Orion Corporation, Finland Hongkiat Trading & Co 30 August 2014 till 29
August 2019
POM
1161 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate) Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 August 2019 till 29
August 2024
POM
1162 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mg Biosis Pharmaceuticals Sdn Bhd.,
Malaysia
K-Seri Pharma Sdn Bhd 30 August 2019 till 29
August 2024
POM
1163 BRU14081449P Mircera Pre-filled Syringe
75mcg/0.3ml
Methoxy polyethylene glycol-
epoetin Beta 75mcg/0.3ml
Roche Diagnostics GmbH,
Germany
MediPharm Sdn Bhd 30 August 2019 till 29
August 2024
POM
1164 BRU14081450P Creobic Cream Clotrimazole 1%w/w Kotra Pharma (M) Sdn Bhd,
Malaysia
Yuh Hua Trading Company 30 August 2019 till 29
August 2024
GSL
1165 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride
5mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 August 2019 till 29
August 2024
P
1166 BRU14081453P Sunex Cough Syrup Per 5ml - Diphenhydramine HCl
14mg; Ammonium chloride 135mg;
Sodium/ Trisodium citrate 57.5mg
Sunward Pharmaceutical Sdn Bhd
Malaysia
G & H Trading Company 30 August 2019 till 29
August 2024
POM
1167 BRU14081455P Proluton Depot 250mg
Injection
Hydroxyprogesterone Caproate
250mg
Bayer Pharma AG, Leverkeusen,
Germany
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1168 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
P
1169 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 30 August 2019 till 29
August 2024
POM
1170 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1171 BRU14081459P Clamentin Powder for Syrup
31.25mg/ml
Per ml - Amoxycillin 25mg (as
trihydrate); Clavulanic acid 6.25mg
(as potassium salt)
Yung Shin Pharmaceutical Ind. Co.,
Ltd, Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
BDMCA/RMP/0319 Page 87 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1172 BRU14081460P Clarimycin Film Coated Tablet
500mg
Clarithromycin 500mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1173 BRU14081461NP Mentar Shampoo Coal Tar solution 9% v/v; Menthol
1% w/w
HOE Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 30 August 2019 till 29
August 2024
GSL
1174 BRU14081462NP Menzza Cream Methyl Salicylate 25%w/w;
Menthol 5%w/w
Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 30 August 2019 till 29
August 2024
GSL
1175 BRU14081463P Difnal OD Tablet 100mg Methyl Salicylate 25%w/w;
Menthol 5%w/w
Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 30 August 2014 till 29
August 2019
POM
1176 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid) PT Bayer Indonesia, Indonesia Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
GSL
1177 BRU14081466P Doridone Tablet 10mg Domperidone 10mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 August 2014 till 29
August 2019
POM
1178 BRU14081467P Tobradex® Eye Drops
Suspension
Tobramycin 0.3%; Dexamethasone
0.1%
S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1179 BRU14081468NP Ferrous Fumarate Tablet
200mg
Ferrous fumarate 200mg
(equivalent to 65mg of elemental
iron)
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 August 2014 till 29
August 2019
GSL
1180 BRU14081469P Tamoxifen 20mg Tablet Tamoxifen 20mg (as citrate
30.4mg)
Teva Pharmaceutical Industries
Ltd, Israel
K-Seri Pharma Sdn Bhd 30 August 2014 till 29
August 2019
POM
1181 BRU14081470P Rotaqor 10mg film-coated
tablet
Atorvastatin 10mg (as calcium) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1182 BRU14081471P;
BRU14081471PS2
Zoral 200 tablet 200mg Acyclovir USP 200mg Drug Houses of Australia Private
Limited, Singapore; PT Actavis
Indonesia, Indonesia (S2)
G & H Trading Company 30 August 2014 till 29
August 2019
POM
1183 BRU14081472P Vamlo Tablets 5mg Amlodipine 5mg (as besilate) Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 30 August 2014 till 29
August 2019
POM
1184 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2019 till 29
August 2024
POM
1185 BRU14081474P Strepsils Max Plus Lozenges 2,4 Dichlorobenzyl alcohol 1.2mg;
amymetacresol 0.6mg; Lignocaine
Hydrochloride 10mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
GSL
1186 BRU14081475P Cera-Scalp Ointment Coal Tar solution 12% w/w;
Salicylic acid 2%; Sulphur 4% w/w
HOE Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 30 August 2019 till 29
August 2024
GSL
1187 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate) Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
BDMCA/RMP/0319 Page 88 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1188 BRU14091477P Suprane Inhalation Liquid
100%
Desflurane 100% Baxter Healthcare Corporation,
Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29
August 2024
POM
1189 BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
P
1190 BRU14091479PS1;
BRU14091479PS2
Cetrotide Injection 0.25mg Cetrotrelix 0.25mg (as Acetate) Baxter Oncology GmbH, Germany
(S1); Pierre Fabre Medicament
Production, France (S2)
G & H Trading Company 30 September 2019 till 29
September 2024
POM
1191 BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline Manufacturing
S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1192 BRU14091481P Xolair Powder and Solvent for
Solution for Injection
Omalizumab 150mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1193 BRU14091482P Frusemide Tablet 40mg Furosemide 40mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1194 BRU14091483P Pengesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading Company 30 September 2019 till 29
September 2024
POM
1195 BRU14091486P Crinone Progestrone Vaginal
Gel 8%
Progestrone 8% Fleet Laboratories Ltd, United
Kingdom
G & H Trading Company 30 September 2019 till 29
September 2024
POM
1196 BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty Ltd.,
Australia
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
GSL
1197 BRU14091488P Defungo (Vaginal Tablet 0.1g) Clotrimazole 0.1g Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 30 September 2019 till 29
September 2024
P
1198 BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as
Hydrochloride)
Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 September 2019 till 29
September 2024
POM
1199 BRU14091490P Trileptal 600mg Film-coated
Tablets
Oxcarbazepine 600mg Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1200 BRU14091491P Binozyt 500mg film-coated
tablet
Azithromycin 500mg (as
monohydrate)
Novartis (Bangladesh) Ltd.,
Bangladesh
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1201 BRU14091492P Nurofen 400 Caplet Ibuprofen 400mg Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
P
1202 BRU14091494P Eprex® 10000 Prefilled
Syringes 10,000iu/1ml
Epoetin alfa 10,000 IU/ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1203 BRU14091495P Metformin Tablet 250mg Metformin Hydrochloride 250mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1204 BRU14091496PS1;
BRU14091496PS2
Hydrochlorothiazide Tablet
50mg
Hydrochlorothiazide BP 50mg Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 30 September 2014 till 29
September 2019
POM
BDMCA/RMP/0319 Page 89 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1205 BRU14091497PS1;
BRU14091497PS2
Famotin Tablet 20mg Famotidine USP 20mg Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1206 BRU14091498P Difenac Tablet 25mg Diclofenac (as Sodium) 25mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1207 BRU14091501P Yucomy cream Ketoconazole 20g/g Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1208 BRU14091502P Loradine Tablet 10mg Loratadine 10mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2019 till 29
September 2024
p
1209 BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1210 BRU14091504P Betoptic S Eye Drops Betaxolol 2.5mg/ml (as
Hydrochloride 2.8mg)
S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1211 BRU14091505P Nurofen Caplet 200mg Ibuprofen 200mg Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
p
1212 BRU14091506P Rhiniramine Syrup 2mg/5ml Dexchlorpheniramine maleate BP
2mg/5ml
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1213 BRU14091507P Afinitor 2.5mg Tablet Everolimus 2.5mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1214 BRU14091508P Glucagen® 1mg Powder and
Solvent for Solution for
Injection
Glucagon 1mg (as hydrochloride) Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1215 BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate
4mg/5ml
Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
p
1216 BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1217 BRU14091511NP 0.9% Sodium Chloride
Injection, B.P. (10ml)
Sodium Chloride 0.9% B. Braun Medical Industries Sdn
Bhd Malaysia
Hongkiat Trading & Co 30 September 2019 till 29
September 2024
GSL
1218 BRU14091512NP Compound Sodium Lactate
Intravenous Infusion B.P.
(Hartmann's Solution)
Per 1000ml contains: Sodium
Chloride 6g; Sodium Lactate
solution 6.24g (50% w/w);
Potassium Chloride 0.40g; Calcium
Chloride dehydrate 0.27g
B. Braun Medical Industries Sdn
Bhd Malaysia
Hongkiat Trading & Co 30 September 2019 till 29
September 2024
POM
1219 BRU14091513P HBVaxPro® 5mcg/0.5ml
Injection
Hepatitis B surface Antigen
5mcg/0.5ml
Merck Sharp & Dohme Corp.,
West Point, Pensylvania, USA
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
BDMCA/RMP/0319 Page 90 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1220 BRU14091514P HBVaxPro® 10mcg/1.0ml
Injection
Hepatitis B surface Antigen
10mcg/1.0ml
Merck Sharp & Dohme Corp.,
West Point, Pensylvania, USA
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1221 BRU14091515P HBvaxPro® 40mcg/1.0ml
Injection
Hepatitis B surface Antigen
40mcg/1.0ml
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1222 BRU14091516P Emthexate 2.5mg Tablet Methotrexate 2.5mg (as disodium) Teva Czech Industries S.R.O.,
Czech Republic
K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1223 BRU14091517P Stalevo 125/31.25/200mg film-
coated tablet
Levodopa 125mg, Carbidopa
31.25mg, Entacapone 200mg
Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1224 BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1225 BRU14091520NP Renacid K8 Each 1 Litre contains: Sodium
Chloride 161.43g, Potassium
Chloride 5.49g, Calcium Chloride
2H2O 6.77g, Magnesium Chloride
6H2O 3.74g, Glacial acetic acid
8.85g
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 30 September 2014 till 29
September 2019
GSL
1226 BRU14091521P Ospexin 500mg Film-coated
Tablets
Cefalexin 500mg (as monohydrate) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1227 BRU14091523NP Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 30 September 2019 till 29
September 2024
GSL
1228 BRU14091524P Melaquin Cream 4% w/w Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2019 till 29
September 2024
P
1229 BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd 30 September 2019 till 29
September 2024
POM
1230 BRU14091526P Glucomet Tablet 500mg Metformin Hydrochloride 500mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1231 BRU14091527P Quemox Tablet 500mg Mebendazole 500mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2019 till 29
September 2024
P
1232 BRU14091528P Campto 300mg/15ml Injection Irinotecan Hydrochloride
Trihydrate 300mg/15ml
Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1233 BRU14091529NP Strepsils Cool Lozenges Each lozenge contains:
Amymetacresol 0.6mg, 2,4-
Dichlorobezyl alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 30 September 2019 till 29
September 2024
GSL
1234 BRU14091530NP Strepsils Sugar Free Lemon
Lozenges
Each lozenge contains:
Amymetacresol 0.6mg, 2,4-
Dichlorobezyl alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 30 September 2019 till 29
September 2024
GSL
1235 BRU14091531P Nordette 21 Tablet Levonogestrel 150mcg, Ethinyl
estradiol 30mcg
Haupt Pharma Munster GmbH.,
Germany
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
BDMCA/RMP/0319 Page 91 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1236 BRU14091533P Ansures Extended Release
Tablet 500mg
Metformin Hydrochloride 500mg Siu Guan Chem, Ind. Co. Ltd.,
Taiwan
G & H Trading Company 30 September 2019 till 29
September 2024
POM
1237 BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1238 BRU14091535NP Livolin Forte Softgel Capsules Per Capsule: Lecithin [PC 35%]
857.13mg (equivalent to
Phosphatidylcholine 300mg), Di-
alpha-tocopheryl acetate 10mg,
Thiamine mononitrate 10mg,
Riboflavin 6mg, Pyridoxine
hydrochloride 10mg, Vitamin B12
0.1% WS 15mg (equivalent to
Vitamin B12 0.015mg),
Nicotinamide 30mg.
Mega Lifesciences Public Company
Limited, Thailand
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
GSL
1239 BRU14091538P Clamentin Injection 1.2g Amoxicillin 1g (as sodium),
Clavulanic acid 0.2g (as clavulanate
potassium)
Yung Shin Phamaceutical Ind. Co
Ltd, Taiwan, ROC
Asterix United (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1240 BRU14091539P ZmaxTM Extended-Release
Granules for Oral Suspension
2g
Azithromycin 2g (as dihydrate) Pfizer Pharmaceuticals LLC Vega
Baja, Puerto Rico
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1241 BRU14091540P Eturion 10mg Film Coated
Tablet
Atorvastatin 10mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC, Puerto
Rico
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1242 BRU14091541P Eturion 20mg Film Coated
Tablet
Atorvastatin 20mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1243 BRU14091542P Eturion 40mg Film Coated
Tablet
Atorvastatin 40mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceutical LLC, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1244 BRU14091543P Eturion 80mg Film Coated
Tablet
Atorvastatin 80mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29
September 2024
POM
1245 BRU14111544P (vial) EYLEA Solution for Injection
(vial)
Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc.,
New York, USA
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1246 BRU14111545P EYLEA Solution for Injection
(pre-filled syringe)
Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc.,
New York, USA
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
BDMCA/RMP/0319 Page 92 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1247 BRU14111546P Binocrit Solution for Injection
2000 IU/ml in Pre-filled
Syringe
Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1248 BRU14111547P Binocrit Solution for Injection
4000 IU/0.4ml in Pre-filled
Syringe
Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1249 BRU14111548P Nootropil Infusion 12g/60ml Piracetam 12g/60ml Aesica Pharmaceuticals SRL., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1250 BRU14111549P Nootropil Injection 1g/5ml Piracetam 1g/5ml UCB Pharma S.P.A., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1251 BRU14111550P Advagraf Prolonged Release
Hard Capsule 0.5mg
Tacrolimus 0.5mg (as
monohydrate)
Astellas Ireland Co Ltd., Ireland MediPharm Sdn Bhd 01 November 2019 till 31
October 2024
POM
1252 BRU14111551P Advagraf Prolonged Release
Hard Capsule 1mg
Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd., Ireland MediPharm Sdn Bhd 01 November 2019 till 31
October 2024
POM
1253 BRU14111552P Advagraf Prolonged Release
Hard Capsule 5mg
Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd., Ireland MediPharm Sdn Bhd 01 November 2019 till 31
October 2024
POM
1254 BRU14111553P Dynastat Powder and Solvent
for Solution for Injection
40mg
Parecoxib (as Sodium) 40mg Pharmacia & Upjohn Company
LLC, USA
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1255 BRU14111554P Invanz Powder for Injection
1g/vial
Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp &
Dohme-Chibret, France
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1256 BRU14111555P Humalog Mix25 100 units/ml
Kwikpen
Insulin Lispro 100IU/ml [In the
proportion of 25% Insulin Lispro &
75% Insulin Lispro Protamine
Suspension (rDNA origin)
Lilly France S.A.S., France (S1)
(repacker - Eli Lilly And Company,
USA)
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1257 BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1258 BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 01 November 2019 till 31
October 2024
GSL
1259 BRU14111558P Trileptal Film-coated Tablets
300mg
Oxcarbazepine 300mg Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1260 BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium
Bicarbonate 1.737g; Citric Acid
(anhydrous) 1.223g.
Bayer de Mexico SA De CV, Mexico Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
GSL
1261 BRU14111560P Voren Plus Gel Diclofenac sodium 10mg/g
(1%w/w)
Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 01 November 2019 till 31
October 2024
GSL
BDMCA/RMP/0319 Page 93 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1262 BRU14111561NP Strepsils Original Lozenges Amylmetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 01 November 2019 till 31
October 2024
GSL
1263 BRU14111562NP Strepsils Orange with Vitamin
C Lozenges
Amylmetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg;
Ascorbic Acid 33.5mg; Sodium
Ascorbate 74.9mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 01 November 2019 till 31
October 2024
GSL
1264 BRU14111563P Loette 21 Tablet Levonorgetsrel 100mcg;
ethinylestradiol 20mcg
Haupt Pharma Munster GmbH.,
Germany
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1265 BRU14111564P Axcel Promethazine-5 Syrup Promethazine Hydrochloride
5mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 01 November 2019 till 31
October 2024
POM
1266 BRU14111565P NIMBEXTM Injection 2mg/ml
(5ml)
Cisatracurium Besylate 10mg/5ml GLaxoSmithKline Manufacturing
S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1267 BRU14111566P Aggrastat Concentrate for
Infusion 0.25mg/ml
Tirofibon 0.25mg/ml (as
hydrochloride monohydrate
0.281mg/ml)
Patheon Manufacturing Services
LLC, USA & Orion Corporation,
Espoo, Finland (repacker)
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1268 BRU14111567P Promezine Syrup 1mg/ml Promethazine Hydrochloride
1mg/ml
Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1269 BRU14111568P Cephanmycin Capsules 500mg Cephalexin 500mg Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1270 BRU14111569P Ferinject® 50mg Iron/ml
solution for Injection/Infusion
Iron 50mg/ml (as ferric
carboxymaltose)
BIPSO GmbH, Germany K-Seri Pharma Sdn Bhd 01 November 2019 till 31
October 2024
POM
1271 BRU14111570P Olmetec Plus 20/12.5mg Film-
coated Tablet
Olmesartan Medoxomil 20mg;
Hydrochlorothiazide 12.5mg
Daiichi Sankyo Europe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1272 BRU14111572P Rotateq® Rotavirus Vaccine,
Live, Oral, Pentavalent
Human-bovine Rotavirus G1 ≥ 2.2 x
106IU; Human-bovine Rotavirus G2
≥ 2.8 x 106IU; Human-bovine
Rotavirus G3 ≥ 2.2 x 106IU; Human-
bovine Rotavirus G4 ≥ 2.0 x 106IU;
Human-bovine Rotavirus P1 ≥ 2.3 x
106IU
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1273 BRU14111573P Eliquis Film-coated Tablets
2.5mg
Apixaban 2.5mg Bristol-Myers Squibb
Manufacturing Company, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1274 BRU14111574P Tren Injection 100mg/ml Tranexamic Acid 100mg/ml Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
BDMCA/RMP/0319 Page 94 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1275 BRU14111575P Ryzodeg Flex Touch 100
units/ml
Per 1 ml: Insulin Degludec 70%;
Insulin Aspart 30%
Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
POM
1276 BRU14111576NP Folic Acid Tablets 5mg Folic Acid BP 5mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 01 November 2014 till 31
October 2019
GSL
1277 BRU14111577NP Dettol Antiseptic Germicide
Liquid
Parachlorometaxylenol 4.8%w/v Pt. Reckitt Benckiser Indonesia Syarikat Aliaa Sdn Bhd 01 November 2019 till 31
October 2024
GSL
1278 BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1279 BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1280 BRU14111580P Somin Tablet 2mg Dexchlorpheniramine Maleate 2mg Y.S.P Industries (M) Sdn. Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1281 BRU14111581P Vaminolact Solution Per 100ml: L-Alanine 6.3 g; L-
Arginine 4.1g; L-Aspartic Acid 4.1g;
L-Cysteine / L-Cystine 1g; L-
Glutamic Acid 7.1g; Glycine (Amino
Acetic Acid) 2.1g; L-Histidine 2.1g;
L-Isoleucine3.1g; L-Leucine 7g; L-
Lysine 5.6g; L-Methionine 1.3g; L-
Phenylalanine 2.7g; L-Proline 5.6g;
L-Serine 3.8g; Taurine 300mg; L-
Threonine 3.6g; L-Tryptophan 1.4g;
L-Tyrosine 500mg; L-Valine 3.6g
Fresenius Kabi Austria GmbH,
Austria
Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31
October 2024
P
1282 BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 01 November 2019 till 31
October 2024
POM
1283 BRU14111583NP Oralite Natural Oral
Rehydration Salts
Per 4.92g sachet: Glucose
anhydrous 3.24g; Sodium Chloride
0.624g; Trisodium citrate dihydrate
0.696g; Potassium Chloride 0.36g
Royce Pharma Manufacturing Sdn.
Bhd., Malaysia
SWL Biomed Sales & Services 01 November 2014 till 31
October 2019
GSL
1284 BRU14111584NP Panamol Forte Suspension
250mg/5ml
Paracetamol 250mg/5ml Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 01 November 2014 till 31
October 2019
P (3.8L)
BDMCA/RMP/0319 Page 95 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1285 BRU14111585PS1,
BRU14111585PS2,
BRU14111585PS3,
BRU14111585PS4
Avastin 100mg/4ml Bevacizumab 25mg/ml (Humanised
anti-VEGF monoclonal antibody)
Genentech Inc., USA (S1); F-
Hoffman-La Roche Ltd, Basel,
Switzerland (S2); Roche
Diagnostics GmbH, Manheim,
Germany (S3); F Hoffmann-La
Roche Ltd, Kaiseraugst,
Switzerland (S4)
Hongkiat Trading & Co 01 November 2019 till 31
October 2024
POM
1286 BRU14111586P Zyvox 20mg/ml Granules For
Oral Suspension
Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1287 BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1288 BRU14111589P Resolor film-coated tablet
1mg
Prucalopride 1mg (as succinate
1.321mg)
Janssen-Cilag SpA., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1289 BRU14111590NP Maltofer Fol Chewable Tablet Iron (III) 100mg (as hydroxide-
polymaltose Complex); Folic acid
0.35mg
Vifor S.A., Switzerland & Iberfar-
Industria Farmacetutica S.A.,
Barcelona, Portugal
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1290 BRU14111591P Pristiq 50mg Extended-
Release Tablets
Desvenlafaxine 50mg (as succinate
75.87mg)
Pfizer Ireland Pharmaceuticals,
Ireland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1291 BRU14111592P ElIquis 5mg Film-coated
Tablet
Apixaban 5mg Bristol-Myers Squibb
Manufacturing Company, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May
2025
POM
1292 BRU14111593P Pulin Film-coated Tablet 10mg Metoclopramide HCl 10mg ( as
Mono HCl 10.5mg)
Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1293 BRU14111595P Advate 250 IU Powder and
Solvent for Solution for
Injection
Octocog alfa (recombinant human
coagulation factor VIII) 250 IU
1) Baxalta Manufacturing Sarl,
Switzerland (DP manufacturer); 2)
Siegfried Hameln GmbH, Germany
(Sterile Water for Injection
(Diluent) manufacturer)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1294 BRU14111596P Glibenclamide Tablet 5mg Glibenclamide 5mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1295 BRU14111597NP 0.45% Sodium Chloride and
5% Dextrose Intravenous
Infusion B.P
Per 1L - Sodium Chloride 4.5g;
Glucose anhdyrous 50g (as
monohydrate 55g)
B.Braun Medical Industries Sdn
Bhd., Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 96 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1296 BRU14111598P Gonal-F 1050IU/1.75ml
(77mcg/1.75ml) Powder and
Solution for Injection
Per Pen (1.75ml) - Follitropin Alfa
1050IU (equivalent 77mcg) [Per ml
of solution contains 600IU
Follitropin alfa ~ 44mcg]
Merck Serono S.p.A., Italy &
Merck Serono S.A., Switzerland
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1297 BRU14111599P Cardiol Tablet 6.25mg Carvedilol 6.25mg Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1298 BRU14111600P Cardiol Tablet 25mg Carvedilol 25mg Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1299 BRU14111602NP BSS® (Balanced Salt Solution)
Sterile Irrigation Solution
Per 1L - Sodium Chloride 6.4g;
Potassium Chloride 0.75g; Calcium
Chloride, dehydrate 0.48;
Magnesium Chloride, hexahydrate
0.3; Sodium Citrate, dehydrate 1.7;
Sodium acetate, trihydrate 3.9
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 19 May 2015 till 18 May
2020
GSL
1300 BRU14111603P Domper Tablet 10mg Domperidone 10mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1301 BRU14111604NP Davmorid film-coated Tablet Diosmin 450mg; Hesperidin 50mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1302 BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1303 BRU14111606NP Strepsils Warm Lozenges Amymetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1304 BRU14111607NP Sodium Bicarbonate 8.4% w/v
Injection (10ml glass ampoule)
Sodium Bicarbonate 8.4%w/v
(84mg/ml)
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1305 BRU14111608P Binozyt 200mg/5ml Powder
for Oral Suspension
Azithromycin 200mg Sandoz S.R.L., Romania Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1306 BRU14111609NP Renacid K4 Per Litre - Sodium Chloride BP
161.43g; Potassium Chloride BP
5.49g; Calcium Chloride 2H2O BP
9.75g; Magnesium Chloride 6H2O
BP 3.74g; Gacial Acetic Acid BP
8.85g
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 97 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1307 BRU14111610NP Renacarb K2 Per Litre - Sodium Chloride BP
30.5g; Sodium Bicarbonate BP
66.0g
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 19 May 2015 till 18 May
2020
POM
1308 BRU14111611P Kogrel 75mg Film Coated
Tablet
Clopidogrel 75mg (as bisulfate
97.875mg)
Sandoz Private Limited, Mumbai,
India
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1309 BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
P
1310 BRU14111613NP Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1311 BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1312 BRU14111615P Curam 156.25mg/5ml Powder
for Oral Suspension
Per 5ml - Amoxycillin 125mg (as
trihydrate); Clavulanic acid
31.25mg
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1313 BRU14111617P Nospan Tablet 30mg Dextromethorphan Hydrobromide
30mg
Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1314 BRU14111618NP Strepsils Extra Strong Lozenge Amymetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1315 BRU14111620P Storvas Tablet 20mg Atorvastatin 20mg (as calcium) Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1316 BRU14111621P Brozil Film coated Tablet
600mg
Gemfibrozil 600mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1317 BRU14111622NP Panadol Extra Tablets Paracetamol 500mg; Caffeine
65mg
Sterling Drug (Malaya) Sdn Bhd,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
19 May 2015 till 18 May
2020
GSL (2 x 6's)
1318 BRU14111623P Botox (Botulinium Toxin, Type
A) Injection 100units/vial
Clostridium Botulinum Toxin Type
A Purified Neurotoxin Complex
100Units/vial
Allergan Pharmaceuticals Ireland,
Ireland
Medipharm Sdn Bhd 19 May 2020 till 18 May
2025
POM
1319 BRU14111624P Botox (Botulinium Toxin, Type
A) Injection 50units/vial
Clostridium Botulinum Toxin Type
A Purified Neurotoxin Complex
50Units/vial
Allergan Pharmaceuticals Ireland,
Ireland
Medipharm Sdn Bhd 19 May 2020 till 18 May
2025
POM
1320 BRU14111625P Botox (Botulinium Toxin, Type
A) Injection 200units/vial
Clostridium Botulinum Toxin Type
A Purified Neurotoxin Complex
200Units/vial
Allergan Pharmaceuticals Ireland,
Ireland
Medipharm Sdn Bhd 19 May 2020 till 18 May
2025
POM
1321 BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1322 BRU14111627P Cellcept Tablet 500mg Mycophenolate mofetil 500mg Roche S.p.A., Italy Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0319 Page 98 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1323 BRU14111628NP 0.45% Sodium Chloride
Intravenous Infusion B.P
Sodium Chloride 0.45% B.Braun Medical Industries Sdn
Bhd., Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
P
1324 BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) PenCef Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1325 BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1326 BRU14111631P Peditrace Concentrate for
Solution for Infusion
Per 1ml - Zinc Chloride 521mcg;
Copper Chloride 2H2O 53.7mcg;
Manganese Chloride 4H2O
3.60mcg; Sodium Selenite
anhydrous 4.38mcg; Sodium
Fluoride 126mcg; Potassium Iodide
1.31mcg
Fresenius Kabo Nolge AS, Norway Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1327 BRU14111633P Pharmaniaga Salbutamol
Respirator Solution 0.5%w/v
Salbutamol 0.5%w/v (as sulphate) Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1328 BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1329 BRU14111635NP Aqueous Cream Emulsifying wax 9.0%w/w; White
Soft Paraffin 15% w/w; Liquid
Paraffin 6.0% w/w
Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1330 BRU14111636P Melomet Cream 0.1% w/w Mometasone Furoate 0.1% w/w Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1331 BRU14111637NP Poro Suspension 250mg/5ml Paracetamol 250mg/5ml Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL ( 60 mL &
100 mL)1332 BRU14111638P Primovists 0.25mmol/ml
solution for injection
Gadoxetic acid, Sodium
0.25mmol/ml
Bayer Pharma AG, Leverkeusen,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1333 BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL (60mL)
1334 BRU14111642P Manace Injection 5mg/ml
(Haloperidol 5mg/ml)
Haloperidol 5mg/ml Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1335 BRU14111643NP Woodward's Gripe Water
(Alcohol Free)
Per 5ml - Terpeneless Dill Seed Oil
2.3mg; Sodium Bicarbonate
52.5mg
IDS Manufacturing Sdn Bhd,
Malaysia
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1336 BRU14111644P Buston Injection 20mg/ml Hyoscine-N-butylbromide 20mg/ml Siu Guan Chem, Ind. Co. Ltd.,
Taiwan
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1337 BRU14111645NP Tolnaderm lotion 1.0%w/v Tolnaftate 1% w/w Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 99 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1338 BRU14111646NP Oralite Orange Oral
Rehydration Salts
Per 4.95g - Glucose anhydrous
3.24g; Sodium Chloride 0.624g;
Trisodium citrate dihydrate 0.696g;
Potassium Chloride 0.36g
Royce Pharma Manufacturing Sdn.
Bhd., Malaysia
SWL Biomed Sales & Services 19 May 2015 till 18 May
2020
GSL
1339 BRU14111647P Vesyca Film Coated Tablet
150mg
Ranitidine 150mg (as
hydrochloride)
Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1340 BRU14111648P Pharmaniaga Cetirizine 10mg
tablet
Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
1341 BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1342 BRU14111650P Invokana Film-coated Tablet
100mg
Canagliflozin 100mg (as
hemihydrate)
JANSSEN ORTHO, LLC, Puerto Rico,
USA [Repacker: Janssen-Cilag SpA,
Italy)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1343 BRU14111651P Axcel Chlorpheniramine-2
Syrup
Chlorpheniramine maleate
2mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
P
1344 BRU14111652P Binozyt Film-Coated Tablet
250mg
Azithromycin 250mg (as
monohydrate)
Novartis (Bangladesh) Ltd.,
Bangladesh
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1345 BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1346 BRU14111654NP Paracetamol Kabi Solution for
infusion 10mg/ml
Paracetamol 10mg/ml i) Fresenius Kabi Deutschland
GmbH, Germany ii) Fresenius Kabi
Austria GmbH, Austria
Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May
2025
POM
1347 BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1348 BRU14121661P Kastipron Tablet 375mg S-Carboxymethylcysteine 375mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1349 BRU14121662P Ipolipid Capsules 300mg Gemfibrozil 300mg Medochemic Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1350 BRU14121663P Curam 625mg Film-coated
Tablet
Amoxicillin 500mg; Clavulanic acid
as potassium salt 125mg
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1351 BRU14121664P Vesyca Injection 25mg/ml Ranitidine (as hydrochloride)
25mg/ml
Yung Shin Pharmaceutical Ind. Co.,
Ltd, Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1352 BRU14121666P Amoxicap 500 Capsule Amoxicillin (as trihydrate 574mg)
500mg
Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1353 BRU14121667NP Wintosal Cream Methyl salicylate 15.0% w/w;
Menthol 2.3% w/w and Camphor
4.0% w/w
Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 100 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1354 BRU14121668NP 50% Glucose Intravenous
Infusion B.P.
Glucose monohydrate (550.00g)
eq. to anhydrous glucose
500.0g/1000ml
B.Braun Medical Industries Sdn
Bhd., Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1355 BRU14121670P Medoflucon Capsule 150mg Fluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1356 BRU14121671P Topamax 100 Tablets 100mg Topiramate 100mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1357 BRU14121672NP Duratears Ocular Lubricant
Ointment
Mineral Oil 30.0mg/g, Anhydrous
liquid lanolin 30.0mg/g and white
petrolatum q.s. ad 1g
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 19 May 2015 till 18 May
2020
GSL
1358 BRU14121673P Eprex® 40,000 Prefilled
Syringes 40,000iu/1ml
Epoetin alfa 40,000IU/ml Vetter Pharma-Fertigung GmbH &
Co. KG, Germany; Cilag AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1359 BRU14121674P Milosec Capsule 20mg Omeprazole 20mg The United Drug (1966) Co. Ltd.,
Thailand
Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1360 BRU14121675P Ziagen Oral Solution Abacavir (as Abacavir Sulfate)
20mg/ml
GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1361 BRU14121676P Minulet 21 Tablet Gestodene 75mcg; ethinylestradiol
30mcg
Haupt Pharma Munster GmbH.,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1362 BRU14121677P Pataday Olopatadine
Ophthalmic Solution 0.2%
Olopatadine hydrochloride 2.22mg
(eq. to Olopatadine 2mg (0.2%)
Alcon Laboratories, Inc., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1363 BRU14121678P Provironum Tablet 25mg Mesterolone 25mg Schering Do Brasil Quimica e
Farmaceutica Ltda., San Paulo-SP,
Brazil
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1364 BRU14121681NP Strepsils Strawberry Sugar
Free Children
Amylmetacresol 0.6mg; 2.4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
International Limited, UK
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1365 BRU14121682P Axcel Sodium Fusidate 250
Tablet
Sodium Fusidate (Micronized)
250mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1366 BRU14121683P Pencor 1mg tablet Doxazosin Mesylate (eq. to
Doxazosin 1mg)
Unison Laboratories Co., Ltd,
Thailand
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1367 BRU14121684P Pencor 2mg tablet Doxazosin Mesylate (eq. to
Doxazosin 2mg)
Unison Laboratories Co., Ltd,
Thailand
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1368 BRU14121685P Pencor 4 Tablet Doxazosin Mesylate (eq. to
Doxazosin 4mg)
Unison Laboratories Co., Ltd,
Thailand
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0319 Page 101 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1369 BRU14121686P Decan Injection 2mg/ml Dexamethasone Sodium
Phosphate 2.2mg (eq. to
Dexamethasone Phosphate 2mg)
Yung Shin Pharmaceutical Ind. Co.,
Ltd, Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1370 BRU14121687P Primodil-10 Tablet Amlodipine Besilate 13.87mg (eq.
to Amlodipine 10mg)
Medley Pharmaceuticals Limited,
India
Medicorp Sdn Bhd 19 May 2020 till 18 May
2025
POM
1371 BRU14121688P Cuvarlix Capsule 120mg Orlistat 120mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1372 BRU14121689NP Calcium Lactate 300mg tablet Calcium lactate 300mg Drug Houses of Australia Pte Ltd.,
Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1373 BRU14121690P Seladin 500mg tablet Naproxen 500mg Y.S.P. Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1374 BRU14121691P Driminate 50mg Suppository Dimenhydrinate 50mg Y.S.P. Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
P (10 x 10's)
1375 BRU14121692NP Hurix's Panau Salap &Gatal-
Gatal Kecil
Zinc oxide 5% w/w; Menthol 1%
w/w; Salicylic Acid/2-
Hydroxybenzoic acid 5% w/w &
Camphor 3% w/w
Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1376 BRU14121693NP Hurix Corn Rid Solution 5%
w/w
lactic Acid 5% w/v; Salicylic Acid
17% w/v
Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1377 BRU14121694NP Hurix Corn Solution 17% Salicylic Acid 0.17g(17%w/v) Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1378 BRU14121695P Axcel Fungicort Cream Miconazole nitrate 2%w/w;
Hydrocortisone 1% w/w
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1379 BRU14121697NP Dettol Antiseptic Wound
Wash Spray
benzalkonium chloride 0.198% Reckitt Benckiser Healthcare (UK)
Ltd., UK
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1380 BRU14121698P Edurant Film-Coated 25mg
tablet
Rilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1381 BRU14121699P Invokana 300mg FCT Canagliflozin 300mg (as
hemihydrate)
JANSSEN ORTHO, LLC, Puerto Rico,
USA [Repacker: Janssen-Cilag SpA,
Italy)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1382 BRU14121700P Amlodipine Tablet 10mg Amlodipine Tablet 10mg Jubilant Generics, Limited, India Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1383 BRU14121701P Borymycin Capsule 100mg Minocycline HCl 100mg Y.S.P., Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1384 BRU14121702NP Septi-Sol Solution Chlorhexidine Gluconate 20%
Solution - 0.5% w/v; Ethanol 94% -
77% v/v
Pahang Pharmacy Sdn Bhd,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 102 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1385 BRU14121703P Atoris Film-coated Tablet
20mg
Atorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1386 BRU14121704NP Nutrilite Glucosamine HCl
Capsule 375mg
Glucosamine HCl 375mg Pharmaniaga Manufacturing
Berhad, Malaysia
Amway Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1387 BRU14121705P Ultibro Breezhaler 110/50
mcg Inhalation Powder Hard
Capsule
Indacaterol (as maleate) 110mcg
(143 mcg); Glycopyrronium (as
bromide) 50mcg (63 mcg)
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1388 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as
anhydrous)
Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1389 BRU15011711P DiSuf-B Cream Fusidic acid (micronized) 2.0% w/w
& Betamethasone 0.1%w/w (as
valerate)
Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1390 BRU15011712NP Dhalumag Suspension Per 5ml - Magnesium trisilicate BP
500mg, Dried Aluminium
Hydroxide BP 250mg
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1391 BRU15011713P Binoclar® 500mg Film-coated
Tablets
Clarithromycin 500mg Novartis Bangladesh Ltd,
Bangladesh
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1392 BRU15011714P Ospamox 250mcg/5ml
granules for suspension
Amoxicillin 250mg (as trihydrate
287mg)
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1393 BRU15011716P Ospamox 500mg Film-coated
Tablet
Amoxicillin 500mg (as trihydrate
574mg)
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1394 BRU15011717P Salofalk® 500mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1395 BRU15011718P Salofalk® 1000mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 1000mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1396 BRU15011719P Vaqta® Vaccine 50U/ml Hepatitis A Virus, Purified,
Inactivated 50U/ml
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1397 BRU15011720P Vaqta® Vaccine 25U/0.5ml Hepatitis A Virus, Purified,
Inactivated 25U/0.5ml
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1398 BRU15011721P Salofalk® 3000mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 3g Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1399 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1% Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0319 Page 103 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1400 BRU15011723P Clarimycin Film Coated Tablet
250mg
Clarithromycin 250mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1401 BRU15011724P Forteo Injection 20mcg/80mcl Each ml contains 250mcg of
Teriparatide (recombinant of
human parathyroid hormone (1-
34) [rhPTH (1-34)])
Lilly France SAS, France Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May
2025
POM
1402 BRU15011725P Torisel Concentrate for
Injection 25mg/ml
Temsirolimus 25mg/ml Pierre Fabre Medicament
Production (PFMP), France
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1403 BRU15011726P Ursofalk 500mg Film-coated
Tablets
Ursodeoxycholic acid 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1404 BRU15011727P Bactigen Eye Drops 0.3% Gentamicin 0.3% (as Gentamicin
Sulphate)
FDC Limited, India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1405 BRU15011728P Hexaxim Suspension for
Injection
Per dose (0.5ml):
Dipththeria toxoid 30 Lf (≥ 20IU),
Tetanus toxoid 10 Lf (≥ 40IU),
Bordetella pertussis antigens:
Pertussis toxoid 25µg, Filamentous
haemagglutinin 25µg, Polio Virus
(Inactivated): Type 1 (Mahoney) 40
DU, Type 2 (MEF-1) 8 DU, Type 3
(Saukett) 32 DU, Hepatitis B
surface antigen 10 µg,
Haemophilus influenzae tybe b
polysaccharide (Polyribosylribitol
phosphate) . 12µg, conjugated to
Tetanus protein (PRP-T) 22-36µg
Sanofi Pasteur Marcy I’Etoile
(MLE), France; Sanofi Pasteur Val
de Reuil, France; Sanofi Pasteur
SPA, Italy
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1406 BRU15011730PS1;
BRU15011730PS3
Bridion Solution for Injection
100mg/ml
Sugammadex 100mg/ml N.V. Organon, The Netherlands
(S1); Patheon Manufacturing
Services LLC, USA (S3)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1407 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1408 BRU15011732NP Strepsils Soothing Honey &
Lemon
Amylmetacresol 0.6ml; 2,4-
Dichlorobenzyl alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 104 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1409 BRU15011733NP Strepsils Max Blackcurrant
Lozenge
Hexylresorcinol 2.4mg Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1410 BRU15011734P Implanon NXT Implant 68mg Etonogestrel 68mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1411 BRU15011735PS2 Stocrin Tablet 200mg Efavirenz 200mg Zhejiang Huahai Pharmaceutical
Co. Ltd., China
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1412 BRU15011736PS2 Stocrin Tablet 600mg Efavirenz 600mg Zhejiang Huahai Pharmaceutical
Co. Ltd., China
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1413 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/v Interphill Laboratories Inc.,
Philippines
LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1414 BRU15011739P Nicotinell TTS 10 Nicotine 17.5mg (delivers
7mg/24hours)
LTS Lohmann Therapie-System AG,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1415 BRU15011740P Nicotinell TTS 20 Nicotine 35mg (delivers 14mg/24
hours)
LTS Lohmann Therapie-System AG,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1416 BRU15011741P Nicotinell TTS 30 Nicotine 52.5mg (delivers 21mg/24
hours)
LTS Lohmann Therapie-System AG,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1417 BRU15011742NP Natzema Eczema Relief Cream Benzoin tincture 10mg/g; Lavender
Angustifolia Oil 5mg/g; Citrus
Sinensis Peel Oil 5mg/g
Cosmetics Manufacturer (Aust)
Pty Ltd, Australia
Bossom Buddies Enterprise 19 May 2015 till 18 May
2020
GSL
1418 BRU15011743P Pharmaniaga Germacid Cream
2%
Fusidic acid 2.0% w/w Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1419 BRU15011744P Extraneal Peritoneal Dialysis
Solution 75g/l (2L Ultrabag)
Each 100ml contains Icodextrin
7.5g, Sodium Chloride 538mg,
Sodium lactate 448mg, Calcium
chloride dihydrate 25.7mg and
Magnesium Chloride Hexahydrate
5.08mg
Baxter Healthcare SA., Singapore
Branch
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1420 BRU15011745P Seladin 250mg tablet Naproxen 250mg Y.S.P Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1421 BRU15011746NP Vitalipid N Adult 1ml contains: Vitamin A 330IU (as
retinoyl palmitate 99mg),
Ergocalciferol 0.5mg(»Vitamin D2
20IU), All-rac-a-Tocopherol
0.91mg(»Vitamin E 1IU),
Phytomenadione (Vitamin K1)
15mg
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0319 Page 105 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1422 BRU15011747NP Vitalipid N Infant 1ml contains: Vitamin A 230IU (as
retinoyl palmitate 69mg),
Ergocalciferol 1.0mg(»Vitamin D2
40IU), All-rac-a-Tocopherol
0.64mg(»Vitamin E 0.71IU),
Phytomenadione (Vitamin K1)
20mg
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1423 BRU15011748P Caslot 6.25mg tablet Carvedilol 6.25mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1424 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1425 BRU15011750NP Prismasol BO Each 1000ml contains (before
reconstitution): Calcium chloride
dihydrate 5.145g, Magnesium
chloride hexahydrate 2.033g,
Lactic acid 5.4g, Sodium chloride
6.45g & Sodium bicarbonate 3.09g
Bieffe Medital S.p.A., Italy Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1426 BRU15021751P Kogenate FS for Injection
1000IU/vial
Antihemophilic factor
(recombinant) sucrose formulated
1000IU
Bayer Healthcare LLC, United
States
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1427 BRU15021752P Kogenate FS for Injection
500IU/vial
Antihemophilic factor
(recombinant) sucrose formulated
500IU
Bayer Healthcare LLC, United
States
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1428 BRU15021753P Dimenate Syrup 15mg/5ml Dimenhydrinate 15mg/5ml Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
POM (3.8L)
BDMCA/RMP/0319 Page 106 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1429 BRU15021754P Cernevit Multivitamin Powder
for Injection
Each vial contains: Retinol
palmitate (VitaminA) 3500 IU,
Cholecalciferol (Vitamin D3) 220
IU, DL alpha tocopherol (Vitamin E)
10.2 mg, Ascorbic acid (Vitamin C)
125mg, Cocarboxylase
tetrahydrate (Vitamin B1) 5.8mg,
Riboflavin sodium phosphate
dehydrate (Vitamin B2) 5.67mg,
Pyridoxine hydrochloride (Vitamin
B6) 5.5mg, Cyanocobalamin
(Vitamin B12) 0.006mg, Folic acid
0.414mg, Dexpanthenol 16.15mg,
Biotin 0.069mg, Nicotinamide
46mg
Baxter SA, Belgium Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1430 BRU15021755P Baneocin Ointment Bacitracin Zinc 250IU/1g;
Neomycin Sulphate 5000 IU
(5mg)/1g
Merck Kommanditgesellschaft Auf
Aktein & Co., Werk, Austria
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1431 BRU15021756P Ospexin 125mg/5ml granules
for oral suspension
Cephalexin 125mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1432 BRU15021757P Simponi Solution for Injection
in Pre-filled Syringe
50mg/0.5ml
Golimumab 50mg/0.5ml Baxter Pharmaceutical Solutions
LLC, USA (Repacker - Cilag AG,
Switzerland)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1433 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1434 BRU15021759P Beclazone 100micrograms CFC-
Free Inhaler
Beclomethasone Dipropionate
100micrograms/metered
inhalation
Norton Waterford T/A Ivax
Pharmaceuticals Ireland
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1435 BRU15021760PS1 &
BRU15021760PS2
Insulatard 100IU/ml
Suspension for Injection (vial)
1ml of suspension contain 100IU
(3.5g) of insulin
Novo Nordisk A/S, Denmark (S1);
Novo Nordisk Production SAS,
France (S2)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1436 BRU15021761P Covapril Tablet 4mg Perindopril Erbumine Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1437 BRU15021762P Axcel Amlodipine 5mg Tablet Amlodipine Besylate equivalent to
Amlodipine 5mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1438 BRU15021763P Neurontin Capsule 400mg Gabapentin 400mg Pfizer Pharmaceuticals LLC.,
Puerto Rico
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0319 Page 107 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1439 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Laboratories Inc., USA Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1440 BRU15021765NP NutrIflex Lipid Plus 1 unit consists of Amino Acid
Solution; Glucose Solution; Lipid
Emulsion* (For Detailed
Formulation referred to Dossier)
B.Braun Melsungen AG, Germany Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1441 BRU15021766P Neulastim Pre-filled Syringe
6mg/0.6ml
Pegfilgrastim 6mg/0.6ml F-Hoffman-La Roche Ltd.,
Switzerland
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1442 BRU15021767P Bacitrecin-N Ointment Bacitracin Zinc 12.5mg (potency)
(Equivalent to Bacitracin Zinc 500
units); Polymyxin B Sulfate 0.83mg
(potency) (Equivalent to Polymyxin
B Sulfate 5,000 units); Neomycin
Sulfate 3.5mg (potency)
Y.s.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1443 BRU15021768P Exelon Patch 15 Rivastigmine base 27mg / 15cm2
(In vivo release rate 13.3mg/24h)
LTS Lohmann Therapie-Systeme
AG, Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1444 BRU15021769NP Zellox-II, Double Strength
Liquid Antacid
Per 10ml - Aluminium Hydroxide
800mg; Magnesium Hydroxide
800mg; Simethicone 60mg
Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1445 BRU15021770P Bonjela Gel 15g tube Choline Salicylate 8.714% &
Cetalkonium chloride 0.01%
Reckitt Benckiser Healthcare (UK)
Ltd., UK
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1446 BRU15021771P Gilenya 0.5mg hard capsule Fingolimod 0.5mg (corresponding
to 0.56mg Fingolimod
Hydrochloride)
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1447 BRU15021772P Presolin 150 tablet Irbesartan 150mg Unison Laboratories Co. Ltd.,
Thailand
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1448 BRU15021773P Presolin 300 tablet Irbesartan 300mg Unison Laboratories Co. Ltd.,
Thailand
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1449 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/ml Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1450 BRU15021775P Hurix Skin Ointment 5%w/w Benzoic acid 5%; Sulphur 25;
Salicyllic acid 5%; Camphor 3%;
Menthol 1% w/w
Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 108 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1451 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1452 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1453 BRU15021779P Trajenta Duo 2.5mg/500mg
FCT tablet
Linagliptin 2.5mg; Metformin
hydrochloride 500mg
Boehringer Ingelheim GmbH and
Co. KG., Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1454 BRU15021780P Trajenta Duo 2.5mg/850mg
FCT
Linagliptin 2.5mg; Metformin
hydrochloride 850mg
Boehringer Ingelheim GmbH and
Co. KG., Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1455 BRU15021781P Trajenta Duo 2.5mg/1000mg
film-coated tablets
Linagliptin 2.5mg; Metformin
hydrochloride 1000mg
Boehringer Ingelheim GmbH and
Co. KG., Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1456 BRU15021783P Acustop Cataplasma Flurbiprofen 40mg Green Cross Corporation, Korea Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1457 BRU15021784P Toviaz 4mg prolonged-release
tablet
Fesoterodine fumarate equivalent
to 3.1mg fesoterodine
Aesica Pharmaceuticals GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1458 BRU15021785P Toviaz 8mg prolonged-release
tablet
Fesoterodine fumarate equivalent
to 6.2mg fesoterodine
Aesica Pharmaceuticals GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1459 BRU15021786P Giotrif 20mg film-coated
tablets (Afatinib 20mg)
Afatinib (as dimaleate) 20mg Boehringer Ingelheim GmbH and
Co. KG., Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1460 BRU15021787P Giotrif 30mg film-coated
tablets (Afatinib 30mg)
Afatinib (as dimaleate) 30mg Boehringer Ingelheim GmbH and
Co. KG., Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1461 BRU15021788P Giotrif 40mg film-coated
tablets (Afatinib 40mg)
Afatinib (as dimaleate) 40mg Boehringer Ingelheim GmbH and
Co. KG., Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1462 BRU15021789P Giotrif 50mg film-coated
tablets (Afatinib 50mg)
Afatinib (as dimaleate) 50mg Boehringer Ingelheim GmbH and
Co. KG., Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1463 BRU15021790P Mikostat oral suspension 30ml
(Nystatin 100,000 IU/ml)
Nystatin 100,000 IU/ml Gulf Pharmaceutical Industries
(Julphar), United Arab Emirates
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1464 BRU15021793NP SMOFlipid 20% Emulsion for
Infusion
1000ml contain: Soya-bean oil,
refined 60 g, Medium-chain
triglycerides 60 g, Olive oil, refined
50 g, Fish oil, rich in omega-2- acids
30 g
Fresenius Kabi Austria GmbH,
Austria
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0319 Page 109 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1465 BRU15021794NP Aminoven 10% Isoleucine 5.00g/L; Leucine 7.4g/L;
Lysine acetate= Lysine 9.31g/L;
Methionine 4.3g/L; Phenylalanine
5.1g/L; Threonine 4.4g/L;
Tryptophan 2.0 g/L; Valine 6.2 g/L;
Arginine 12.0g/L; Histidine 3.0 g/L,
Alanine 14.0 g/L, Glycine 11.0 g/L;
Proline 11.2 g/L; Serine 6.5g/L;
Tyrosine 0.4g/L; Taurine 1.0g/L.
Fresenius Kabi Austria GmbH,
Austria
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1466 BRU15021795P Ceflour CFT 250mg Cefuroxime (as Cefuroxime Axetil)
250mg
Yung Shin Pharmaceutical Ind. Co.
Ltd., Republic of China
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1467 BRU15021796P Montelair 10mg film-coated
tablet
Montelukast (as Montelukast
Sodium) 10mg
Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1468 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine
Besilate) 10mg
Lek Pharmaceuticals D.D., Solvenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1469 BRU15021798NP Dianeal Low Calcium
(2.5MEq/L) Peritoneal Dialysis
Solution with 4.25% Dextrose
(2L Ultrabag)
Each 100ml contains: Dextrose
Hydrous 4.25g; Sodium Chloride
538mg; Sodium Lactate 448mg;
Calcium Chloride dihydrate
18.3mg; and Magnesium Chloride
Hexhydrate 5.08mg
Baxter Healthcare SA., Singapore
Branch
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1470 BRU15021799NP Dianeal Low Calcium
(2.5MEq/L) Peritoneal Dialysis
Solution 2.5% Dextrose (2L
Ultrabag and 2.5L Ultrabag)
Each 100ml contains: Dextrose
Hydrous 2.5g; Sodium Chloride
538mg; Sodium Lactate 448mg;
Calcium Chloride dihydrate
18.3mg; and Magnesium Chloride
Hexhydrate 5.08mg
Baxter Healthcare SA., Singapore
Branch
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1471 BRU15021800NP Dianeal Low Calcium
(2.5MEq/L) Peritoneal Dialysis
Solution 1.5% Dextrose (2L
Ultrabag and 2.5L Ultrabag)
Each 100ml contains: Dextrose
Hydrous 1.5g; Sodium Chloride
538mg; Sodium Lactate 448mg;
Calcium Chloride dihydrate
18.3mg; and Magnesium Chloride
Hexhydrate 5.08mg
Baxter Healthcare SA., Singapore
Branch
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1472 BRU15021801NP Calactate 300mg tab Calcium Lactate pentahydrate
300mg
Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 110 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1473 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1474 BRU15021803P Colospan 10mg sugar coated
tablet
Hyoscine Butylbromide 10mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1475 BRU15021804P Caslot 25mg tablet Carvedilol 25mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1476 BRU15021805P Serenata 50mg Tablet Sertraline hydrochloride 56mg
equivalent to Sertraline 50mg
Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1477 BRU15021806P Gammaplex 5% w/v 2.5g Human Immunoglobulin G
2.5g/50ml
Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1478 BRU15021807P Gammaplex 5% w/v 5g Human Immunoglobulin G
5g/100ml
Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1479 BRU15021808P Gammaplex 5% w/v 10g Human Immunoglobulin G
10g/200ml
Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1480 BRU15031809P Moxiclav Forte Dry Powder for
Oral Suspension 312.5mg/5ml
Amoxicillin (as trihydrate) 250mg &
Clavulanic acid 62.5mg
Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May
2020
POM
1481 BRU15031810P Moxiclav 625mg Tablets Amoxicllin trihydrate (574mg)
500mg; clavulanate potassium
microcrystalline cellulose
(297.8mg) eq. to clavulanic acid
125mg
Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May
2020
POM
1482 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Hospira S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1483 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May
2020
POM
1484 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0319 Page 111 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1485 BRU15031814P NimenrixTM (Meningococcal
polysaccharide serogroups
A,C,W-135, Y) Vaccine
MenAAH-TT-conjugate (Mean TT/PS
ratio:3) 5mcg PSA~15mcg TT,
MenCAH-TT-conjugate (Mean TT/PS
ratio:3) 5mcg PSC~15mcg TT,
MenW-TT-conjugate (Mean TT/PS
ratio:1.5) 5mcg PSW~7.5mcg TT,
MenY-TT-conjugate (Mean TT/PS
ratio:1.3) 5mcg PSY~6.5mcg TT
Glaxosmithkline Biologicals s.a.,
Rixensart, Belgium;
GlaxoSmithKline Biologicals,
Branch of SmithKline Beecham
Pharma GmbH & Co. KG., Dresden
Germany (diluent Ampoule);
Delpharm Tours, Chambray-lès-
Tours
France (Diluent ampoule);
GlaxoSmithKline Biologicals SA,
Rixensart Belgium (diluent PFS);
Catalent Belgium SA, Brussels,
Belgium (diluent PFS);
GlaxoSmithKline Biologicals S.A. ,
Wavre Belgium (Additional facility
for formulation)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1486 BRU15031816P Cialis 5mg Tablet Tadalafil 5mg Lilly del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May
2025
POM
1487 BRU15031817P Cialis 20mg Tablet Tadalafil 20mg Lilly del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May
2025
POM
1488 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mg Duopharma (M) Sdn. Bhd.,
Malaysia
Hongkiat Trading & Company 19 May 2015 till 18 May
2020
P (50 x 10’s)
1489 BRU15031819P Placta Film-coated Tablets
75mg
Clopidogrel (as bisulphate) 75mg Actavis Ltd., Malta G&H Trading Company 19 May 2015 till 18 May
2020
POM
1490 BRU15031820NP SmofKabiven Peripheral
Emulsion for Infusion
1 unit consists of Amino Acid
Solution; Glucose Solution; Lipid
Emulsion (For detailed formulation
referred to dossier)
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1491 BRU15031821P Ometec capsule 20mg Omeprazole 20mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0319 Page 112 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1492 BRU15031823P ADVATE 500IU Powder and
Solvent for Solution for
Injection
Octocog alfa (recombinant human
coagulation factor VIII)
1) Baxalta Manufacturing Sarl,
Switzerland (DP manufacturer);
2) Siegfried Hameln GmbH,
Germany (Sterile Water for
Injection (Diluent) manufacturer)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1493 BRU15031824NP Livovid Forte Capsule Lecithin soya bean (300mg
phosphatidyl choline) 858.0mg,
Thiamine hydrochloride (4.7mg
vitamin B1) 6mg, Riboflavin 6mg,
Pyridoxine hydrochloride (4.93mg
of vitamin B6) 6mg,
Cyanocobalamin 0.006mg,
Nicotinamide 30mg, dl-alpha-
tocopherol acetate 6IU
Hovid Bhd., Malaysia G&H Trading Company 19 May 2015 till 18 May
2020
GSL
1494 BRU15031825P Saizen® Liquid 12mg (8mg/ml) Somatropin 12mg/1.5ml
(recombinant human growth
hormone)
Merck Serono S.p.A., Italy G&H Trading Company 19 May 2015 till 18 May
2020
POM
1495 BRU15031826P Saizen® Liquid 6mg
(5.83mg/ml)
Somatropin 6mg/1.03ml
(recombinant human growth
hormone)
Merck Serono S.p.A., Italy G&H Trading Company 19 May 2015 till 18 May
2020
POM
1496 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
1497 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
1498 BRU15031830NP Gaviscon Liquid Sachet Each 10ml contains: Sodium
alginate 500mg, Sodium
bicarbonate 267mg and Calcium
carbonate 160mg
Reckitt Benckiser Healthcare (UK)
Ltd., UK
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1499 BRU15031831NP Fisherman’s Friend Sugar-Free
Apple & Cinnamon Lozenges
Menthol 4.025mg IDS Manufacturing Sdn. Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn. Bhd.
19 May 2015 till 18 May
2020
GSL
1500 BRU15031832NP Fisherman’s Friend Sugar-Free
Mandarin & Ginger Lozenges
Menthol 4.6mg IDS Manufacturing Sdn. Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn. Bhd.
19 May 2015 till 18 May
2020
GSL
1501 BRU15031833NP Fisherman’s Friend Sugar-Free
Lemon Lozenges
Menthol 4.6mg IDS Manufacturing Sdn. Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn. Bhd.
19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 113 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1502 BRU15041834P Rotaqor 20mg film-coated
tablet
Atorvastatin Calcium 20mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1503 BRU15041835P Jakavi 20mg tablet Ruxolitinib (as phosphate 26.40mg)
20mg
Novartis Pharma Stein, AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1504 BRU15041836P Jakavi 15mg tablet Ruxolitinib (as phosphate 19.8mg)
15mg
Novartis Pharma Stein, AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1505 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg)
5mg
Novartis Pharma Stein, AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1506 BRU15041839P Archifar 500mg powder for
injection/infusion
Meropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus Hong Kiat Trading & Co. 19 May 2015 till 18 May
2020
POM
1507 BRU15041840P Ciproflo 2mg/ml solution for
IV infusion
Ciprofloxacin 2mg/ml (as
hydrochloride)
Sin Guan Chem. Ind. Co. Ltd.,
Republic of China
K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
1508 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1509 BRU15041842P B-Mycin cream Betamethasone dipropionate
0.643mg (eq. to 0.5mg
betamethasone); Gentamicin
Sulfate 1mg (potency)
Y.S.P. Industries (M) Sdn. Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1510 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5ml Sunward Pharmaceutical Sdn.
Bhd., Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
1511 BRU15041844P Pharmaniaga Loratadine
tablet 10mg
Loratadine 10mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
1512 BRU15041845P Curam 1000mg tablet Amoxycillin 875 (as trihydrate);
clavulanic acid 125mg (as
potassium clavulanate)
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1513 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride)
500mg
Fisiopharma S.r.L., Italy K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
1514 BRU15041847P Sunadine tablet 10mg Loratadine 10mg Sunward Pharmaceutical Sdn.
Bhd., Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
BDMCA/RMP/0319 Page 114 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1515 BRU15041848NP Soluvit N Powder for Solution
for Infusion
Thiamine mononitrate 3.1mg
(corresponding to vitamin B1
2.5mg); Riboflavine sodium
phosphate 4.9mg (corresponding
to vitamin B2 3.6mg);Nicotinamide
40mg; Pyridoxine hydrochloride
4.9mg (corresponding to vitamin
B6 4.0mg); Sodium panthothenate
16.5mg (corresponding to
pantothenic acid 15.0mg); Sodium
ascorbate 113mg (corresponding
to Vitamin C 100mg); Biotin
60mcg; Folic acid 0.40mg;
cyanocobalamin 5.0mcg
Sino Swed Pharmaceutical Corp.
Ltd., China
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1516 BRU15041849NP Folic acid 5mg tablet Folic acid 5mg Sunward Pharmaceutical Sdn.
Bhd., Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
1517 BRU15041850P Estelle-35 tablet Cyproterone acetate 2mg;
Ethinylestradiol 0.03mg
Douglas Manufacturing Limited,
New Zealand
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1518 BRU15041851NP Cetomacragol emulsifying
ointment
Cetomacragol emulsifying wax 30%
w/w; liquid paraffin 20%; white
soft paraffin 50%
Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1519 BRU15041852PS1/
BRU15041852PS2
Glucophage® XR 1000mg
Extended-release tablet
Metformin (as hydrochloride
1000mg) 780mg
1. Merck Sante SAS, France;
2. Merck KGaA, Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1520 BRU15041853P Duofilm Liquid Salicylic acid 16.7% w/w; lactic acid
16.7%
Stiefel Labs (Ireland) Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
P
1521 BRU15041854NP Voluven Solution for Infusion
6%
Per 1000ml: Poly (O-2-
hydroxyethyl) starch 60.0g; sodium
chloride 9.00g
Frensius Kabi Deutschland GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1522 BRU15041855NP Iris eye drops Hydroxypropyl methylcellulose
3mg; dextran 70 1mg
Sam Chun Dang Pharm Co Ltd,
South Korea
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1523 BRU15041856P Onzapin film-coated tablet
5mg
Olanzapine 5mg Actavis Ltd., Malta G & H Trading Company 19 May 2015 till 18 May
2020
POM
1524 BRU15041857P Onzapin film-coated tablet
10mg
Olanzapine 10mg Actavis Ltd., Malta G & H Trading Company 19 May 2015 till 18 May
2020
POM
1525 BRU15041858NP Fisherman’s friend aniseed
lozenges
Menthol 5.75mg Lofthouse of Fleetwood Limited,
UK
Kingston Beverage &
Creamery Sdn Bhd
19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/0319 Page 115 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1526 BRU15041859NP Fisherman’s Friend Sugar
Free Mint Lozenges
Menthol 3.45mg Lofthouse of Fleetwood Limited,
UK
Kingston Beverage &
Creamery Sdn Bhd
19 May 2015 till 18 May
2020
GSL
1527 BRU15041860NP Fisherman’s Friend Sugar Free
Cherry Lozenges With
Menthol 6.9mg
Menthol 6.9mg Lofthouse of Fleetwood Limited,
UK
Kingston Beverage &
Creamery Sdn Bhd
19 May 2015 till 18 May
2020
GSL
1528 BRU15041861NP ChlorHex 5% Concentrate
Solution
Chlorhexidine gluconate 5% w/v;
isopropylalcohol 3.15% w/v
Pahang Pharmacy Sdn Bhd,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1529 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mg Upha Pharmaceuticals Sdn Bhd,
Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1530 BRU15051863NP SP Pharma Paracetamol
Tablets 500mg
Paracetamol 500mg Simpor Pharma Sendirian Berhad,
Brunei Darussalam
Simpor Pharma Sendirian
Berhad
19 May 2015 till 18 May
2020
P (200’s)
1531 BRU15051864NP Addamel™ N Concentrate for
Infusion
1 mL contains: Chromic chloride 6
H2O 5.33 µg; Copper chloride 2
H2O 340 µg; Ferric chloride 6 H2O
540 µg; Manganese chloride 4 H2O
99 µg; Potassium iodide 16.6 µg;
Sodium fluoride 210 µg; Sodium
molybdate 2 H2O 4.85 µg; Sodium
selenite anhydrous 6.90 µg; Zinc
chloride 1.36 mg
Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1532 BRU15051865NP Dettol Moisturing Formula
Antiseptic Cream
Triclosan 0.3%; Chloroxylenol 0.3%;
Edetic acid 0.2%
Reckitt Benckiser Healthcare (UK)
Ltd., UK
Syarikat Aliaa Sdn Bhd 28 July 2015 till 27 July 2020 GSL
BDMCA/RMP/0319 Page 116 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1533 BRU15051867NP Kabiven Peripheral Emulsion
for Infusion
1000ml of the mixture contain:
Purified soybean oil 35g; Glucose
(anhydrous) 68g; Alanine 3.3g;
Arginine 2.4g; Aspartic acid 0.71g;
Phenylalanine 1.6g; Glutamic acid
1.2g; Glycine 1.6g; Histidine 1.4g;
Isoleucine 1.2g; Leucine 1.6g;
Lysine 1.9g; Methionine 1.2g;
Proline 1.4g; Serine 0.94g;
Threonine 1.2g; Tryptophan 0.40g;
Tyrosine 0.05g; Valine 1.5g;
Sodium glycerophosphate
(anhydrous) 1.0g; Calcium chloride
0.15g; Potassium chloride 1.2g;
Magnesium sulphate 0.33g;
Sodium acetate 1.0g
Fresenius Kabi AB, Uppsala,
Sweden
Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1534 BRU15051868NP Kabiven Emulsion for Infusion 1000ml of the mixture contain:
Purified soybean oil 39g; Glucose
(anhydrous) 97g; Alanine 4.7g;
Arginine 3.3g; Aspartic acid 0.99g;
Phenylalanine 2.3g; Glutamic acid
1.6g; Glycine 2.3g; Histidine 2.0g;
Isoleucine 1.6g; Leucine 2.3g;
Lysine 2.6g; Methionine 1.6g;
Proline 2.0g; Serine 1.3g;
Threonine 1.6g; Tryptophan 0.56g;
Tyrosine 0.07g; Valine 2.1g;
Sodium glycerophosphate
(anhydrous) 1.5g; Calcium chloride
0.22g; Potassium chloride 1.7g;
Magnesium sulphate 0.47g;
Sodium acetate 1.4g
Fresenius Kabi AB, Uppsala,
Sweden
Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1535 BRU15051869P Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM
BDMCA/RMP/0319 Page 117 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1536 BRU15051870P Fenagesic Tablet 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 28 July 2015 till 27 July 2020 POM
1537 BRU15051871P Metta SR Tablets 500mg Metformin Hydrochloride USP
500mg
Torrent Pharmaceuticals Ltd.,
Indrad, India
K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM
1538 BRU15051872P Diamitex Tablet 80mg Gliclazide 80mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM
1539 BRU15051873NP Calamine Lotion Calamine BP 15% w/v Royce Pharma Manufacturing Sdn
Bhd, Malaysia
SWL Biomed Sales & Services 28 July 2015 till 27 July 2020 GSL
1540 BRU15051874NP Fisherman’s Friend Original
Lozenges
Menthol 10.35mg; Eucalyptus oil
1.73mg
Lofthouse of Fleetwood Limited,
UK
Kingston beverage &
Creamary Sdn Bhd
28 July 2015 till 27 July 2020 GSL
1541 BRU15051875NP Fisherman’s Friend Mint
Lozenges
Menthol 4.6mg; Peppermint oil
11.270mg
Lofthouse of Fleetwood Limited,
UK
Kingston beverage &
Creamary Sdn Bhd
28 July 2015 till 27 July 2020 GSL
1542 BRU15051876NP Fisherman’s Friend Sugar Free
Original Lozenges
Menthol 9.2mg IDS Manufacturing Sdn Bhd,
Malaysia
Kingston beverage &
Creamary Sdn Bhd
28 July 2015 till 27 July 2020 GSL
1543 BRU15051878P Loratyn-10 Loratadine 10mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM (100's); P
(20's)1544 BRU15051879P Candazole V Single Dose
Cream 10% w/w
Clotrimazole 10% w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 28 July 2015 till 27 July 2020 P
1545 BRU15061880P Keppra® Oral Solution
100mg/ml
Levetiracetam 10mg/ml NextPharma SAS., France Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1546 BRU15061881P Norditrophin Nordilet
Inejction 5mg/1.5ml Pre-filled
Pen, Solution for Injection
Somatropin (rDNA) 3.3mg/ml Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1547 BRU15061882P Aceprin 10mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM
1548 BRU15061883NP Povidone Iodine solution 10%
w/v
Povidone Iodine 10% w/v Royce Pharma Manufacturing Sdn.
Bhd., Malaysia
SWL Biomed Sales & Services 28 July 2015 till 27 July 2020 GSL
1549 BRU15061884P Pharmaniaga Cephalexin
Suspension 250mg
Cephalexin (as Cephalexin
Anhydrous) 250mg/5mL
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 28 July 2015 till 27 July 2020 POM
1550 BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 28 July 2015 till 27 July 2020 POM
1551 BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1552 BRU15061887NP PVP Iodine Solution Povidone-Iodine 10% w/v
(equivalent to 1% available Iodine)
Dynapharm (M) Sdn. Bhd.,
Malaysia
Medicorp Sdn Bhd 28 July 2015 till 27 July 2020 GSL
BDMCA/RMP/0319 Page 118 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1553 BRU15061888P Herceptin Powder for
Injection 440mg/vial
Trastuzumab 440mg Genentech Inc., California, USA;
Genentech Inc., Oregon, USA
MediPharm Sdn Bhd 28 July 2015 till 27 July 2020 POM
1554 BRU15061889P Azoren 20mg/5mg Film-
Coated Tablet
Olmesartan medoxomil 20mg and
Amlodipine (as
amlodipine besylate) 5mg
Daiichi Sankyo Europe GmbH,
Germany [repacker: Pfizer
Manufacturing Deutschland
GmBH, Germany]
Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1555 BRU15061890P Azoren 40mg/10mg Film-
Coated Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as
amlodipine besylate) 10mg
Daiichi Sankyo Europe GmbH,
Germany [repacker: Pfizer
Manufacturing Deutschland
GmBH, Germany]
Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1556 BRU15061891P Azoren 40mg/5mg Film-
Coated Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as
amlodipine besylate) 5mg
Daiichi Sankyo Europe GmbH,
Germany [repacker: Pfizer
Manufacturing Deutschland
GmBH, Germany]
Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1557 BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg
(eqv. to 3.338mg perindopril)
Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1558 BRU15061893NP Mentholatum Deep Heating
Rub
Methyl Salicylate 12.7% & Menthol
5.8%
The Mentholatum Co., Inc., USA Hamitan Marketing 28 July 2015 till 27 July 2020 GSL
1559 BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam)
Co. Ltd., Vietnam
Hamitan Marketing 28 July 2015 till 27 July 2020 GSL
1560 BRU15061895NP Oxy Acne Wash Triclosan 0.30% Rohto-Mentholatum (Vietnam)
Co. Ltd., Vietnam
Hamitan Marketing 28 July 2015 till 27 July 2020 GSL
1561 BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd.,
Malaysia
Medicorp Sdn. Bhd. 28 July 2015 till 27 July 2020 GSL
1562 BRU15061897NP Gaviscon Advance Peppermint Sodium alginate 500mg/5ml
Potassium bicarbonate 100mg/5ml
Reckitt Benckiser Healthcare (UK)
Ltd., UK
Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 GSL
1563 BRU15071899P Cavumox 625mg Tablet Amoxicillin (as trihydrate) 500mg;
Clavulanic acid (as potassium salt)
125mg
Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1564 BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg;
Sodium bicarbonate 267mg;
Calcium carbonate 160mg
Reckitt Benckiser Healthcare (UK)
Ltd, UK
Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
BDMCA/RMP/0319 Page 119 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1565 BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd, Taiwan G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1566 BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D.,
Ljubljana
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1567 BRU15071903NP Chlorhex 4% antiseptic
solution
Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd.,
Malaysia
G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
1568 BRU15071904P Resolor Film-coated Tablet
2mg
Prucalopride succinate 2.642mg
eqv Prucalopride 2mg
Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1569 BRU15071905P Proglutrol 500 Extended
Release Tablets
Metformin Hydrochloride 500mg Inventia Healthcare Pvt. Ltd., India Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1570 BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg;
Sodium Bicarbonate 213mg;
Calcium Carbonate 325mg
Reckitt Benckiser Healthcare (UK)
Ltd, UK
Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1571 BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium
Bicarbonate 106.5mg; Calcium
Carbonate 187.5mg
Reckitt Benckiser Healthcare (UK)
Ltd, UK
Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1572 BRU15071908P Daivobet Gel Calcipotriol (as monohydrate)
50mcg/g & betamethasone (as
dipropionate) 0.5mg/g
LEO Laboratories Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1573 BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam)
Co. Ltd., Vietnam
Hamitan Marketing 09 Dec 2015 till 08 Dec 2020 GSL
1574 BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum (Vietnam)
Co. Ltd., Vietnam
Hamitan Marketing 09 Dec 2015 till 08 Dec 2020 GSL
1575 BRU15071911P Hydrogen Peroxide Solution
(6%)
Hydrogen Peroxide 6% w/v
(equivalent to 20 volumes of
available oxygen)
The Government Pharmaceutical
Organization, Thailand
SWL Biomed Sales & Services 09 Dec 2015 till 08 Dec 2020 GSL
1576 BRU15071912P Keppra Film-coated Tablet
1000mg
Levetiracetam 1000mg UCB Pharma SA, Belgium Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1577 BRU15081913NP Zentel Suspension
400mg/10ml
Albendazole 400mg/10ml Smithkline Beecham, Philippines Kingston Beverage &
Creamery Sdn Bhd
09 Dec 2015 till 08 Dec 2020 GSL (1's x 10ml)
1578 BRU15081914P Xalacom Eye Drops 1ml contains latanoprost 50
micrograms and timolol maleate
6.8mg (eq to 5mg timolol)
Pfizer Manufacturing Belgium NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1579 BRU15081916P Unihepa 5000IU/ml Injection
(5ml vial)
Heparin sodium 5000IU/ml Duopharma (M) Sdn Bhd.,
Malaysia
K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1580 BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
BDMCA/RMP/0319 Page 120 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1581 BRU15081918P Olanzapine Orodispersible
Tablets 5mg
Olanzapine 5mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1582 BRU15081919P Olanzapine Orodispersible
Tablets 10mg
Olanzapine 10mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1583 BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical
Laboratories, India
K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1584 BRU15081921P Pharmaniaga Dermapro
Ointment 0.05% w/w
Clobetasol propionate 0.05% w/w Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1585 BRU15081922P Olmetec Plus 40/12.5mg Film-
Coated Tablet
Olmesartan Medoxomil 40mg;
Hydrochlorothiazide 12.5mg
Daiichi Sankyo Europe GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1586 BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1587 BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1588 BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1589 BRU15081926NP Win-Aqueous Cream Emulsifying Wax 8%w/w; Liquid
Paraffin 5% w/w; White
Soft Paraffin 13% w/w
Winwa Medical Sdn Bhd., Pulau
Pinang, Malaysia
Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1590 BRU15091928P Acular Ophthalmic Solution
0.5%
Ketorolac Tromethamine 0.5% Allergan Pharmaceuticals Ireland,
Ireland
MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1591 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mg Pfizer Pharmaceuticals LLC, Vega
Baja, USA (Pfizer Vega Baja)
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1592 BRU15091930P Zymar (gatifloxacin
ophthalmic solution) 0.3%
Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1593 BRU15091931P Klerimed 500mg Film-Coated
Tablets
Clarithromycin 515mg (equivalent
to anhydrous clarithromycin
500mg)
1. Medochmie Ltd (Factory AZ),
Cyprus
2. Medochmie Ltd (Central
Factory), Cyprus
Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1594 BRU15091932P Gadovist Injection
1.0mmol/ml Prefilled syringe
5.0ml
Gadobutrol pure 604.72mg &
Calcium sodium butrol 0.513mg
Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1595 BRU15091933P Gadovist Injection
1.0mmol/ml
Gadobutrol pure 604.72mg &
Calcium sodium butrol 0.513mg
Bayer AG, MÜllerstraβe 178,
Germany
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
BDMCA/RMP/0319 Page 121 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1596 BRU15091934P Neostigmine Methysulphate –
Fresenius 2.5mg/1ml
(Ampoules)
Neostigmine methylsulphate
2.5mg/ml
Fresenius Kabi Manufacturing SA
(Pty) Ltd., Republic of South Africa.
K-Seri Pharma Sdn. Bhd. 09 Dec 2015 till 08 Dec 2020 POM
1597 BRU15091935P Cardiprin 100 Tablet Aspirin 100mg Reckitt Benckiser Healthcare
(UK),United Kingdom
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1598 BRU15091936P Calact 300mg Tablets Calcium Lactate USP Eq. to Calcium
Lactate Pentahydrate 300mg.
Elemental Calcium 39mg (from
Calcium lactate pentahydrate
300mg).
Unique Pharmaceutical
Laboratories (A Division of J.B.
Chemicals & Pharmaceuticals
Limited), India.
K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1599 BRU15091937P Guafensin Syrup 20mg/ml Guaifenesin 20mg/ml Y.S.P. Industries (M) Sdn. Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1600 BRU15091938P Storvas C Tablets 10mg Atorvastatin 10mg as Atorvastatin
Calcium Trihydrate
Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1601 BRU15091939NP Zinc Cream Zinc Oxide 32% w/w HOE Pharmaceuticals Sdn. Bhd.,
Malaysia
G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
1602 BRU15091940P Pirimat Injection 10mg/ml
(1ml ampoule)
Chlorpheniramine Maleate
10mg/m
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1603 BRU15091941P Irprestan Tablet 150mg Irbesartan 150mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1604 BRU15091942P Irprestan Tablet 300mg Irbesartan 300mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1605 BRU15091943P Heparinol® 10 Sterile
Heparinised Saline Injection
Heparin Sodium (Bovine) 10 IU/ml Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 POM
1606 BRU15091944P Fucid Ointment 2% w/w Sodium Fusidate (Micronised)
20mg/g (2% w/w)
Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1607 BRU15091946P Axcel Bromhexine (Children)
Elixir
Bromhexine Hydrochloride 4mg Kotra Pharma (M) Sdn Bhd.,
Malaysia
Medicorp Sdn Bhd. 09 Dec 2015 till 08 Dec 2020 POM
1608 BRU15101947P Cetyrol 10mg Film-coated
Tablet
Cetirizine dihydrochloride 10mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 P
1609 BRU15101948P Archifar 1g Powder for
Solution for Injection/Infusion
Meropenem (as trihydrate) 1g Medochemie Ltd., Cyprus Hongkiat Trading & Co 09 Dec 2015 till 08 Dec 2020 POM
1610 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate
2mg/5ml
Winwa Medical Sdn Bhd.,
Malaysia
Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 P
BDMCA/RMP/0319 Page 122 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1611 BRU15101950P Respidon 2mg Tablets Risperidone 2mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1612 BRU15101951P Respidon 1mg Tablets Risperidone 1mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1613 BRU15101952NP Flexjoint 1500mg Powder Crystalline glucosamine sulphate
1884mg (equivalent to
glucosamine sulphate 1500mg)
Winwa Medical Sdn Bhd.,
Malaysia
Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1614 BRU15101953NP Colin Cough Syrup 100mg Guaiphenesin 100mg/5ml Winwa Medical Sdn Bhd.,
Malaysia
Yuh Hua Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
1615 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 units T.O. Chemicals (1979) Co. Ltd.,
Thailand
Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1616 BRU15101955P Ezede Tablet 10mg Loratadine 10mg Xepa-Soul Pattinson (M) Sdn Bhd.,
Malaysia
Hongkiat Trading & Co 09 Dec 2015 till 08 Dec 2020 P
1617 BRU15101956P Pred Forte Sterile Ophthalmic
Suspension 1%
Prednisolone acetate 1% w/v Allergan Pharmaceuticals Ireland,
Mayo, Ireland
Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1618 BRU15111957P Stivarga Tablet 40mg Regorafenib
(40mg Regorafenib equivalent to
41.49mg Regorafenib
monohydrate)
Bayer Pharma AG, Germany. Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1619 BRU15111958P A Scabs Lotion Permethrin 5.0% w/v HOE Pharmaceuticals Sdn. Bhd.,
Malaysia
G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
1620 BRU15111959P Insugen-N (NPH) Insulin Injection, Isophane Ph. Eur.
(Human Insulin rDNA origin)
100IU/ml
Biocon Limited, India Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1621 BRU15111960P Tetradox Capsules 100mg Doxycycline Hydrochloride/Hcylate
eq to Doxycycline 100mg
Ranbaxy (Malaysia) Sdn Bhd,
Malaysia
G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1622 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/v AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 GSL
1623 BRU15111962NP Infusol W (Sterilised Water for
Injection BP)
Water for injection BP AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 GSL (500ml)
1624 BRU15111963P Elan Forte Cream Tolnaftate 10mg/g; Chlorhexidine
HCl 2mg/g
Y.S.P. Industries (M) Sdn.
Bhd.,Malaysia
Asterix United (B) Sdn Bhd. 09 Dec 2015 till 08 Dec 2020 GSL
1625 BRU15111964P Valparin XR 500mg Tablet i) Sodium Valproate 333mg
ii) Valproic Acid 145mg
(Both together correspond to
sodium valproate 500mg)
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd., 09 Dec 2015 till 08 Dec 2020 POM
BDMCA/RMP/0319 Page 123 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1626 BRU15111965P Axcel Betamethasone Cream Betamethasone 17-Valerate
(micronized) equivalent to
Betamethasone 0.1% w/w
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1627 BRU15111966P Freederm Gel Terbinafine HCl 1%w/w Winwa Medical Sdn Bhd.,
Malaysia
Yuh Hua Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
1628 BRU15111967P Cough-En Linctus Dextromethorphan Hydrobromide
15mg/5ml;
Tripolidine Hydrochloride
1.25mg/5ml;
Pseudoephedrine Hydrochloride
30mg/5ml
Xepa-Soul Pattinson (Malaysia)
Sdn. Bhd., Malaysia
Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1629 BRU15111968PT Atehexal Comp Mite Tablet Atenolol 50mg; Chlorthalidone
12.5mg
Salutas Pharma GmbH, Federal
Republic of Germany
Medicorp 09 Dec 2015 till 28 April
2019
POM
1630 BRU15111969PT Hurricaine Topical Anaesthetic
Gel – Original Wild Cherry
Benzocaine 20% Dental Technologies Inc. , United
States
L S Kai Care 09 Dec 2015 till 16 Feb 2018 POM
1631 BRU15111970PT Duocaine Cream 5% w/w Lidocaine 2.5% w/w; Prilocaine
2.5% w/w
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Co 09 Dec 2015 till 14 Jan 2019 POM
1632 BRU15121972PS1 &
BRU15121972PS2
Varivax (refrigerated) Varicella Virus Vaccine Live (Oka /
Merck) 1350PFU / 0.5ml
Merck Sharp & Dohme Corp.,
Pennsylvania USA (S1)
ii) Merck Sharp and Dohme Corp.,
North Carolina, US (S2)
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1633 BRU15121973P SW-Dexasone Tablet Dexamethasone 0.5mg Sunward Pharmaceutical Sdn Bhd.,
Singapore
G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1634 BRU15121974P Paracetamol Codeine Tablet Paracetamol 500mg and Codeine
Phosphate 8mg
Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1635 BRU15121975NP Mentholatum Deep Heat
Sport Pain Relief Spray
Methyl Nicotinate 16mg/g; Glycol
Salicylate 50mg/g; Methyl
Salicylate 10mg/g; Ethyl salicylate
50mg/g
Ensign Labs Pty. Ltd., Australia Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL
1636 BRU15121976NP Mentholatum Deep Cold Ice
Gel Therapy
Menthol 20g/g Mentholatum Australia Pty. Ltd.,
Australia
Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL
1637 BRU15121977NP Axcel Urea Cream Urea 10% w/w Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1638 BRU15121979P Medocef 1g Powder for
Solution for Injection or
Infusion
Cefoperazone (as sodium) 1g Medochemie Ltd., Cyprus Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
BDMCA/RMP/0319 Page 124 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1639 BRU15121980NP Dexxon Lozenges Dequalinium Chloride 0.25mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1640 BRU15121981P Oragel Pain Relief Choline Salicylate 9% w/w &
Cetylpyridinium Chloride 0.05%
w/w
Winwa Medical Sdn. Bhd.,
Malaysia
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1641 BRU16011982NP 0.9% Sodium Chloride
Injection, USP
Sodium Chloride USP 0.9% Baxter Healthcare Corporation,
USA
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1642 BRU16011983P Amlibon 5mg Tablet Amlodipine (as Amlodipine
Besilate) 5mg
Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1643 BRU16011984P Ospexin 250mg/5ml Granules
for Oral Suspension
Cephalexin 250mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1644 BRU16011985P Azukon MR 30mg Tablet Gliclazide 30mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1645 BRU16011986P Espran 10mg Tablet Escitalopram (as Oxalate) 10mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1646 BRU16011987P Zenalb 20% Human albumin 20%w/v Bio Product Lab, UK Medipharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1647 BRU16011988P Lestric Tablets 20mg Lovastatin 20mg Ranbaxy (Malaysia) Sdn Bhd.,
Malaysia
G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1648 BRU16011989P Potassium Chloride 10% w/v
Injection
Potassium Chloride 10% w/v Pharmaniaga Manufacturing
Berhad, Malaysia
G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1649 BRU16011990P Gastografin Solution 1ml contains Sodium
amidotrizoate 0.1g and Meglumine
amidotrizoate 0.66g
Belimed SA, Spain Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1650 BRU16011991P Rabotide Capsule 20mg (as
enteric coated pellets)
Rabeprazole Sodium 20mg Inventia Healthcare Pvt Ltd., India Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1651 BRU16011992P Pharmaniaga Gliclazide Tablet
80mg
Gliclazide 80mg Pharmaniaga Manufacturing
Berhad, Malaysia
G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1652 BRU16011993NP Betadine Antiseptic Ointment Povidone-Iodine 10% w/w Pt. Mahakam Beta Farma,
Indonesia
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1653 BRU16011994NP Betadine Feminine Wash with
Douching Apparatus 10% w/v
Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma,
Indonesia
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1654 BRU16011995NP Betadine Feminine Wash Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma,
Indonesia
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1655 BRU16011996NP Coxan Tablets 500mg Paracetamol 500mg Prime Pharmaceuticals Sdn Bhd.,
Malaysia
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL (10 x 10’s)
BDMCA/RMP/0319 Page 125 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1656 BRU16011997P Soluwax Ear Drops Docusate sodium 0.5% w/v Hoe Pharmaceuticals Sdn Bhd.,
Malaysia
G&H Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1657 BRU16021998P Insugen-R (NPH) Insulin Injection, Soluble Ph. Eur.
(Insulin, Human of recombinant
DNA origin) 100 IU/ml
Biocon Limited, India Hongkiat Trading & Co 21 Jun 2016 till 20 Jun 2021 POM
1658 BRU16021999P Levetiracetam tablet 500mg Levetiracetam 500mg Jubilant Generics, Limited, India Axterix United (B) Sdn. Bhd 21 Jun 2016 till 20 Jun 2021 POM
1659 BRU16022000P Glimicron 80mg tablet Gliclazide 80mg HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 POM
1660 BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 GSL
1661 BRU16022002NP Noxworm Suspension
(chocolate) 400mg
Albendazole 200mg/5mL Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1662 BRU16022003P Mircera pre-filled syringe
100mcg/0.3ml
Methoxy polyethylene glycol-
epoetin beta 100mcg/0.3ml
Roche Diagnostics GmbH,
Germany
MediPharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1663 BRU16022006P Rocaltrol capsule 0.25mcg Calcitriol 0.25mcg Catalent Germany Eberbach
GmbH, Germany for F.Hoffmann-
La Roche Ltd., Switzerland
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM
1664 BRU16022007P Adezio Oral Suspension Cetirizine Hydrochloride 1mg/ml Xepa-Soul Pattinson (Malaysia)
Sdn Bhd,
Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 P
1665 BRU16022008P Zarin cream Miconazole nitrate 2%w/w Xepa-Soul Pattinson (Malaysia)
Sdn Bhd,
Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL
1666 BRU16022010P Bena
®
Expectorant
Diphenhydramine hydrochloride
14mg/5ml and ammonium
chloride 135mg/5ml
Xepa-Soul Pattinson (Malaysia)
Sdn Bhd,
Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM
1667 BRU16022011P Pantor 20 Pantoprazole (as sodium
sesquihydrate) 20mg
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1668 BRU16022012P Pantor 40 Pantoprazole (as sodium
sesquihydrate) 40mg
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1669 BRU16032013P Ceritec Film Coated Tablet
10mg
Cetirizine Hydrochloride 10mg Y.S.P. Industries (M) Sdn. Bhd.,
Malaysia.
Asterix United (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P
1670 BRU16032014P Tinazol Cream 2% (15g) Miconazole nitrate 2% w/w Hovid Bhd, Malaysia. G & H Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
BDMCA/RMP/0319 Page 126 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1671 BRU16032015PS1 &
BRU16032015PS2
M-M-R II® Vaccine Live, attenuated virus derived from
Edmonston B strain of measles -
3.0 log TCID50, Live attenuated Jeryl
LynnTM strain of mumps - 4.1 log
TCID50, Live, attenuated Wistar RA
27/3 strain of rubella - 3.0 log
TCID50
1. Merck Sharp & Dohme Corp.,
Pennsylvania, USA,
2. Merck Sharp & Dohme Corp.,
North Carolina, U.S.A
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1672 BRU16032016P Insugen-30/70 (Biphasic) Insulin Injection, Biphasic Isophane
Ph. Eur. (Insulin, Human
recombinant DNA origin) 100
IU/ml
Biocon Limited, India Hongkiat Trading & Co. 21 Jun 2016 till 20 Jun 2021 POM
1673 BRU16032017P Natrixam 1.5mg/10mg
modified-release tablet
Indapamide 1.5mg & Amlodipine
10mg (as besilate)
Les Laboratories Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1674 BRU16032018P Natrixam 1.5mg/5mg
modified-release tablet
Indapamide 1.5mg & Amlodipine
5mg (as besilate)
Les Laboratories Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1675 BRU16032019P Levetiracetam 250mg tablet Levetiracetam 250mg Jubilant Generics Limited, India Asterix United (B)Sdn Bhd., 21 Jun 2016 till 20 Jun 2021 POM
1676 BRU16032020NP Mifuko Ointment Zinc Oxide 6% (w/w) and Salicylic
acid 5% (w/w)
Winwa Medical Sdn Bhd,
Malaysia.
Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1677 BRU16032021P Primodil 5 Tablet Amlodipine Besilate 6.94mg
(equivalent to Amlodipine 5mg)
Medley Pharmaceuticals Ltd, India Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1678 BRU16032022P Oxair Film Coated Tablet
10mg
Montelukast Sodium 10.4mg
(equivalent to Montelukast 10mg)
Y.S.P. Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1679 BRU16032023NP Bacidin Antiseptic Cream 1%
w/w
Chlorhexidine Gluconate 1% w/w Xepa-soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL
1680 BRU16032024P Axcel Oxymetazoline 0.05%
Nasal Spray
Oxymetazoline Hydrochloride
0.05% w/v
Kotra Pharma (M) Sdn Bhd.,
Malaysia.
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P
1681 BRU16042025P Romesec 20mg Capsules Omeprazole USP 20mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia.
G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
BDMCA/RMP/0319 Page 127 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1682 BRU16042026NP Migrate Q10 Coenzyme Q10………….100mg;
Lycopene………………….... 5mg; L-
Arginine…………….…..100mg;
Zinc Sulphate monohydrate (eq to
Elemental zinc)..22.5mg;
Piperine………………………..5mg;
Sodium selenite (eq to Elemental
selenium) ….70mcg
Goodman Pharmaceuticals, India. MediBiotech 21 Jun 2016 till 20 Jun 2021 GSL
1683 BRU16042027NP Potassium Chloride Injectable
Solution 10%
Potassium chloride 1g / 10ml DEMO SA Pharmaceutical
Industry, Greece.
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1684 BRU16042028P Oratane 20mg Capsules Isotretinoin 20mg Swiss Caps AG, Switzerland,
Contract Mfg. for Douglas
Pharmaceuticals Limited, New
Zealand.
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1685 BRU16042029P Oratane 10mg Capsules Isotretinoin 10mg Swiss Caps AG, Switzerland,
Contract Mfg. for Douglas
Pharmaceuticals Limited, New
Zealand.
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1686 BRU16042030NP Osteoactiv 3 in 1 Joint
Formula Powder
Glucosamine Hydrochloride
1000mg, Methylsulfonylmethane
1000mg, Chondroitin Sulphate
Sodium 880.4mg (equivalent to
800mg chondroitin)
Winwa Medical Sdn. Bhd.,
Malaysia.
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1687 BRU16042031NP Osteoactiv 3 in 1 Joint
Formula Tablet
Glucosamine Hydrochloride
250mg, Methylsulfonylmethane
250mg, Chondroitin Sulphate
Sodium 220mg (equivalent to
200mg chondroitin)
Winwa Medical Sdn. Bhd.,
Malaysia.
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1688 BRU16042032P Sedilix-DM Linctus Dextromethorphan (as
Hydrobromide) 15mg/5mL;
Pseudoephedrine (as
Hydrochloride) 30mg/5mL;
Promethazine (as Hydrochloride)
3.125mg/5mL
Xepa-Soul Pattinson (M) Sdn Bhd,
Malaysia.
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM
1689 BRU16042033P Aloxi Solution for Injection
50mcg/ml
Palonosetron Hydrochloride 56
mcg eqv to Palonosetron 50 mcg
(0.050 mg)
Pierre-Fabre Medicament
Production, France.
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
BDMCA/RMP/0319 Page 128 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1690 BRU16042034P Taver Tablet 200mg Carbamazepine 200mg Medochemie Ltd., Cyprus. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1691 BRU16042035NP Axcel B Complex Tablet Vitamin B1 10mg; Vitamin B2
3mg; Vitamin B6 1mg;
Cyanocobalamine 5mcg; Calcium
Pantothenate 1mg; Nicotinamide
25mg
Kotra Pharma (M) Sdn Bhd,
Malaysia.
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1692 BRU16042036P Pharmaniaga Allopurinol
Tablet 300mg
Allopurinol 300mg Pharmaniaga Manufacturing
Berhad, Malaysia.
G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1693 BRU16042037NP Povidin Solution 10% Povidone-Iodine 10% w/v
(equivalent to 1% of Available
Iodine)
Xepa-soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL
1694 BRU16052038P GPO-L-OneTM 500mg Tablet Deferiprone 500mg The Government Pharmaceutical
Organization (GPO), Thailand
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1695 BRU16052039NP Noxworm Chewtab Albendazole 200mg Winwa Medical Sdn. Bhd.,
Malaysia
Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1696 BRU16052040NP Betadine® Antiseptic Solution Povidone-Iodine 10% w/v PT Mahakam Beta Farma,
Indonesia
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1697 BRU16052041P Zoratadine Syrup 5mg/5ml Loratadine 5mg/5ml HOE Pharmaceuticals Sdn. Bhd.,
Malaysia
G&H Trading Company 21 Jun 2016 till 20 Jun 2021 P
1698 BRU16052042P Axcel Oxymetazoline 0.025%
Nasal Drop
Oxymetazoline hydrochloride
0.025% w/v
Kotra Pharma (M) Sdn. Bhd.,
Malaysia
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P
1699 BRU16052044P;
BRU16052044PS2
Zometa Solution for Infusion
4mg/100ml
Zoledronic Acid (anhydrous)
4mg/100ml corresponding to
4.264mg Zoledronic Acid
Monohydrate
Novartis Pharma Stein AG,
Switzerland; Fresenius Kabi
Austria GmbH, Austria
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1700 BRU16052045P Novomin Tablet 50mg Dimenhydrinate 50mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia.
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM
1701 BRU16062046P Valzaar 80mg Tablets Valsartan 80mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1702 BRU16062047P Valzaar 160mg Tablets Valsartan 160mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1703 BRU16062048P Tozaar 50mg tablet Losartan potassium 50mg Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021
POM
1704 BRU16062049P Seebri Breezhaler 50mcg
Inhalation Powder Hard
Capsules
Glycopyrronium bromide 63mcg
(corresponding to 50 mcg
Glycopyrronium)
Novartis Pharma Stein AG.,
Switzerland
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
BDMCA/RMP/0319 Page 129 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1705 BRU16062050P Neotigason Capsule 10mg Acitretin 10mg Patheon Inc., Canada G & H Trading Company 08 November 2016 till 07
November 2021
POM
1706 BRU16062051P Neotigason Capsule 25mg Acitretin 25mg Patheon Inc., Canada G & H Trading Company 08 November 2016 till 07
November 2021
POM
1707 BRU16062052P Tidact Injection 150mg/ml Clindamycin (as phosphate)
150mg/ml
Yung Shin Pharmaceutical Ind. Co.
Ltd., Republic of China
Asterix United (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1708 BRU16062053P APO-Risperidone Tablets 1mg Risperidone 1mg Apotex Inc, Canada Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1709 BRU16062054P Betmiga Prolonged-Release
Tablets 25mg
Mirabegron 25mg Avara Pharma Technologies, Inc.,
USA
Medipharm Sdn Bhd 08 November 2016 till 07
November 2021
POM
1710 BRU16062055P Betmiga Prolonged-Release
Tablets 50mg
Mirabegron 50mg Avara Pharma Technologies, Inc.,
USA
Medipharm Sdn Bhd 08 November 2016 till 07
November 2021
POM
1711 BRU16062056P Axcel Mometasone 0.1%
Cream
Mometasone furoate (micronised)
0.1% w/w
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1712 BRU16072057P Dipeptiven Infusion 200mg/ml N(2)-L-Alanyl-L-glutamine
200mg/ml
Frensius Kabi Austria GmbH,
Austria
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1713 BRU16072058P Noxafil 100mg tablet Posaconazole 100mg N.V Organon, Netherlan Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1714 BRU16072059P Onegaba 300mg capsules Gabapentin 300mg Aurobindo Pharma Limited (Unit
III), India
K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021
POM
1715 BRU16072060P Pethidine-Hameln Solution for
Injection 50mg/ml
Pethidine Hydrochloride
50mg/ml
Hameln Pharmaceuticals GmbH,
Langes Feld 13, 31789 Ham
eln, Germany
Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1716 BRU16072061P Axcel Clobetasol 0.05
Ointment
Clobetasol Propionate (micronized)
0.05% w/w
Kotra Pharma (M) Sdn Bhd.,
Malaysia.
Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1717 BRU16072062P Prednisolone syrup 5mg/5ml Each 5ml contains:
Prednisolone (as salt of
prednisolone) 5mg
Beacons Pharmaceutical Pte Ltd,
Singapore
Hong Kiat Trading & Co 08 November 2016 till 07
November 2021
POM
1718 BRU16082063NP Zenalb 4.5%, Human Albumin
Solution 4.5%
Human Albumin Solution 4.5% Bio Products Laboratory Limited,
UK
MediPharm Sdn Bhd 08 November 2016 till 07
November 2021
POM
1719 BRU16082064P Axcel Lamivudine 100mg
Tablet
Lamivudine 100mg Kotra Pharma (M) Sdn. Bhd.,
Malaysia
Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1720 BRU16082065P Calpo Suspension Mebendazole 100mg/5ml Winwa Medical Sdn. Bhd.,
Malaysia
Yuh Hua Trading Company 08 November 2016 till 07
November 2021
GSL
1721 BRU16082066NP Alphanate® 250IU Factor VII 250IU and von
Willebrand Factor >400IU/1000IU
Factor VII
Grifols Bilogicals Inc., USA Hongkiat Trading & Company 08 November 2016 till 07
November 2021
POM
BDMCA/RMP/0319 Page 130 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1722 BRU16082067P Anoro Ellipta 62.5/25
micrograms inhalation
powder, pre-dispensed
Each pre-dispensed dose contains
62.5 micrograms umeclidinium
(equivalent to 74.2 micrograms of
umeclidinium bromide) and 25
micrograms vilanterol (as
trifenatate)
GlaxoSmithKline LLC, North
Carolina United States
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1723 BRU16082068NP RINS® NS Sodium Chloride
0.9% w/v Irrigation Solution
BP
Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 08 November 2016 till 07
November 2021
GSL
1724 BRU16092069P Sifrol Extended Release
0.375mg tablet
Pramipexole
Dihydrochloride
Monohydrate 0.375mg
(eq
v.
to 0.26mg
pramipexole free base)
Boehringer Ingelheim Pharma
gmbH & Co. KG, Germany
Hongkiat Trading & Company 08 November 2016 till 07
November 2021
POM
1725 BRU16092070P Sifrol Extended Release 1.5mg
tablet
Pramipexole
Dihydrochloride
Monohydrate 1.5mg
(eqv. to 1.05mg
pramipexole free base)
Boehringer Ingelheim Pharma
gmbH & Co. KG, Germany
Hongkiat Trading & Company 08 November 2016 till 07
November 2021
POM
1726 BRU16092071NP Mentholatum Deep Heating
Rub Extra Strength Cream
Methyl Salicylate 30%; Menthol
8%
The Mentholatum Co., USA. Hamitan Marketng, Brunei
Darussalam
08 November 2016 till 07
November 2021
GSL
1727 BRU16092072P GlobalVacc Al-Shifa HIB Each dose of 0.5ml contains:
Purified Capsular Polysaccharide
Hib
(PRP) –10mcg
(Hib Polysaccharide) (PRP) Tetanus
Toxoid (carrier protein) –19 to
33mcg
Serum Institute India Ltd., India Bruvac Pharma Sdn Bhd 08 November 2016 till 07
November 2021
POM
1728 BRU16092073P Adrenaline (Epinephrine)
Injection 1:1000
Adrenaline (Epinephrine) as acid
tartrate
Mc Carthys Laboratories Ltd., UK Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1729 BRU16092074P Axcel Mometasone 0.1%
Ointment Mometasone Furoate
(micronised) 0.1% w/w
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
BDMCA/RMP/0319 Page 131 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1730 BRU16092075P Amphotret for Injection U.S.P.
50mg
Amphotericin B U.S.P. 50mg Bharat Serums And Vaccines Ltd,
India
K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021
POM
1731 BRU16092076NP Alumag Plus Tablet Per tablet:
Aluminium Hydroxide Dried Gel
250mg; Magnesium Trisilicate Light
250mg; Simethicone
30mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
HongKiat Trading Co 08 November 2016 till 07
November 2021
GSL
1732 BRU16102077PT Olanzapine Genmark 10mg
Tablet
Olanzapine 10mg Glenmark Pharmaceuticals Europe
Limited, United Kingdom
Hongkiat Trading & Company 08 November 2016 till 23
Nov 2018
POM
1733 BRU16102078PT Olanzapine Genmark 5mg
Tablet
Olanzapine 5mg Glenmark Pharmaceuticals Europe
Limited, United Kingdom
Hongkiat Trading & Company 08 November 2016 till 14
Jan 2019
POM
1734 BRU16102079PT Baxter Chlorhexidine Acetate
0.1% w/v Antiseptic Solution
Chlorhexidine (as
Acetate)
Baxter Healthcare Pty Ltd,
Australia
Zuellig Pharma (B) Sdn Bhd 08 November 2019 till 26
Jan 2024
GSL
1735 BRU16102080P Magurol 2mg tablet Doxazosin mesilate eq. to
doxazosin base 2
mg
Medochemie Ltd Central Factory,
Cyprus
Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1736 BRU16102081P Magurol 4mg tablet Doxazosin mesilate eq. to
doxazosin base 4
mg
Medochemie Ltd Central Factory,
Cyprus
Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1737 BRU16102082P Xyzal Film-coated tablet 5mg Levocetirizine dihydrochloride
5mg
UCB Farchim SA, Switzerland Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
P
1738 BRU16102083P Xolair 75mg powder for
solution for injection
Omalizumab 75mg.
Reconstituted Xolair contains
125mg/ml of omalizumab (75mg
in
0.6ml)
Novartis Corporation (Malaysia)
Sdn. Bhd., Malaysia
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1739 BRU16102084P Bilaxten 20mg tablet Bilastine 20mg A.Menarini Manufacturing Logistic
and Services S.r.l., Italy
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1740 BRU16102085P Loxin Injection (5ml amp)
(Dopamine HCl)
Dopamine hydrochloride Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 08 November 2016 till 07
November 2021
POM
1741 BRU16102086P Mycamine 50mg/vial Powder
for Solution for Infusion
Micafungin (as sodium)
50mg/via
Astellas Pharma Tech Co., Ltd.,
Japan
MediPharm Sdn Bhd 08 November 2016 till 07
November 2021
POM
BDMCA/RMP/0319 Page 132 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1742 BRU16102087P Vaxcel Fluconazole 2mg/ml IV
Infusion
Fluconazole 2mg/ml Kotra Pharma (M) Sdn.
Bhd.,Malaysia
Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1743 BRU16102088P Sellon Shampoo Selenium sulfide 2.5% w/v Unison Laboratories Co., Ltd.,
Thailand
K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021
P
1744 BRU16102089NP Daily-vite multivitamin syrup
for children
Each 5mL contains:
Vitamin A: 2,000 IU
Vitamin D :400 IU
Vitamin B1 (Thiamine HCl): 1.5 mg
Vitamin B2 (Riboflavin): 1.2 mg
Vitamin B6 (Pyridoxine HCl): 1.0
mg
Vitamin B12 (cyanocobalamin): 3.0
mcg
Niacinamide: 10mg
Vitamin C (Ascorbic Acid): 50 mg
L-Lysine Monohydrochloride: 37.5
mg
Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
GSL
1745 BRU16102090NP Ubat Batuk Cap Kaki Tiga
(Solution)
Guaifenesin 100mg/5ml Syarikat Wen Ken Drug Sdn Bhd, ,
Malaysia
Syarikat Rajamas Bersama 08 November 2016 till 07
November 2021
GSL
1746 BRU16102091P Vaxcel Lignocaine 1% Injection Lignocaine Hydrochloride
1% (50mg/5ml)
Kotra Pharma (M) Sdn.
Bhd.,Malaysia
Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1747 BRU16112092P Risperidone Orally
Disintegrating Tablet 3mg
Risperidone 3.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd 21 March 2017 till
20 March 2022
POM
1748 BRU16112093P Risperidone Orally
Disintegrating Tablet 2mg
Risperidone 2.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd 21 March 2017 till
20 March 2022
POM
1749 BRU16112094P Goutnor 0.5mg tablet Colchicine 0.5mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd. 21 March 2017 till
20 March 2022
POM
1750 BRU16112095P Salbutamol Syrup 2mg/5ml Salbutamol sulphate 2mg/5ml Y.S.P. Industries (M) Sdn. Bhd.,
Malaysia
Asterix United (B) Sdn Bhd. 21 March 2017 till
20 March 2022
POM
1751 BRU16112096P Ospexin 1000mg Film-coated
Tablet
Cephalexin 1000mg Sandoz GmBH, Austria Zuellig Pharma (B) Sdn Bhd. 21 March 2017 till
20 March 2022
POM
1752 BRU16112097NP Noflux Tablet 90mg Lysozyme chloride 90mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd. 21 March 2017 till
20 March 2022
GSL
1753 BRU16112098NP Calamine Lotion with Menthol Calamine powder 15% w/v, zinc
oxide 5% w/v and menthol 0.4%
w/v
Beacons Pharmaceuticals Pte Ltd.,
Singapore
Hongkiat Trading & Company 21 March 2017 till
20 March 2022
GSL
BDMCA/RMP/0319 Page 133 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1754 BRU16112099P Toujeo 300 units/ml Solution
For Injection In Pre-Filled Pen
Insulin glargine 300units/ml
(10.91mg/ml)
Sanofi-Aventis Deutschland
GmbH, Germany
MediPharm Sdn Bhd. 21 March 2017 till
20 March 2022
POM
1755 BRU16112100P Apo-Levocarb Tablet
100mg/25mg
Levodopa 100mg; Carbidopa 25mg Apotex Inc., Canada Medicorp Sdn Bhd, 21 March 2017 till
20 March 2022
POM
1756 BRU16112101P Exviera 250mg Film Coated
Tablets
Dasabuvir (as sodium
monohydrate) 250mg
AbbVie Ireland NL B.V, Ireland Zuellig Pharma (B) Sdn Bhd 21 March 2017 till
20 March 2022
POM
1757 BRU16112102NP White Balsem, Three Legs
Brand
Methyl salicylate 18% w/w,
Menthol 9% w/w and Camphor 5%
w/w
Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 21 March 2017 till
20 March 2022
GSL
1758 BRU16112103NP Tinea Skin Solution, Three
Legs Brand
Salicylic acid 5% w/v and Benzoic
acid 2% w/v
Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 21 March 2017 till
20 March 2022
GSL
1759 BRU16112104NP Three Legs Yellow Lotion Acriflavine 0.1%w/v Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 21 March 2017 till
20 March 2022
GSL
1760 BRU16112105P Furosemide-hameln 10mg/ml
Injection
Furosemide 10mg/ml Hameln Pharmaceuticals
GmbH,Germany
Medicorp Sdn Bhd 21 March 2017 till
20 March 2022
POM
1761 BRU16112106NP Tolnaftate Cream Three Legs
Brand
Tolnaftate 1% w/v Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 21 March 2017 till
20 March 2022
GSL
1762 BRU16112107NP Ubat Serbuk Cap Kaki Tiga
600mg/sac
Acetylsalicylic acid (Aspirin) 600mg
/ sachet
Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 21 March 2017 till
20 March 2022
GSL
1763 BRU16112108P Denkan (1) Injection i) Lignocaine HCl monohydrate eq.
to Lignocaine HCl Anhydrous 20mg
(2%w/v)
ii) Epinephrine Acid Tartrate eq. to
Epinephrine 0.01mg (1:100 000)
Duopharma (M) Sdn Bhd.,
Malaysia.
K-Seri Pharma Sdn Bhd. 21 March 2017 till
20 March 2022
POM
1764 BRU16112109NP 5% Dextrose in 0.9% Sodium
Chloride Solution for
Intravenous Infusion
Each 100ml contains: Dextrose
monohydrate 5.00g and Sodium
Chloride 900mg
Euro-Med Laboratories Phil., Inc.,
Philippines
Medicorp Sdn Bhd 21 March 2017 till
20 March 2022
POM
1765 BRU16112110P Zylovaa Tablet 100mg Losartan potassium 100mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 21 March 2017 till
20 March 2022
POM
1766 BRU16122111P Ceflour Injection 0.75g Cefuroxime Sodium 0.75g Yung Shin Pharmaceutical Ind. Co.
Ind., Republic of China
K-Seri Pharma Sdn. Bhd. 21 March 2017 till
20 March 2022POM
1767 BRU16122112P Ziagen Tablets 300mg Abacavir 300mg (as abacavir
sulphate)
GlaxoSmithKline Pharmaceuticals
S.A., Poland
Zuellig Pharma (B) Sdn Bhd 21 March 2017 till
20 March 2022POM
1768 BRU16122113P Apo-Alendronate 70mg tablet Alendronate Sodium Trihydrate eq
to Alendronic acid 70mg
Apotex Inc. Canada MediPharm Sdn Bhd 21 March 2017 till
20 March 2022POM
BDMCA/RMP/0319 Page 134 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1769 BRU16122114P Tensiber Film Coated Tablet
300mg
Irbesartan 300mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma (B) Sdn Bhd 21 March 2017 till
20 March 2022POM
1770 BRU16122115P Cala-My Lotion Calamine 15% w/v, Zinc Oxide 5%
w/v
HOE Pharmaceuticals Sdn. Bhd.,
Malaysia
G & H Trading Company 21 March 2017 till
20 March 2022GSL
1771 BRU16122116P Apo-Quetiapine 25mg Tablet Quetiapine Fumarate equivalent to
25mg Quetiapine
Apotex Inc, Canada MediPharm Sdn Bhd 21 March 2017 till
20 March 2022POM
1772 BRU16122117P Apo-Quetiapine 100mg Tablet Quetiapine Fumarate equivalent to
100mg Quetiapine
Apotex Inc, Canada MediPharm Sdn Bhd 21 March 2017 till
20 March 2022POM
1773 BRU16122118P Apo-Quetiapine 200mg Tablet Quetiapine Fumarate equivalent to
200mg Quetiapine
Apotex Inc, Canada MediPharm Sdn Bhd 21 March 2017 till
20 March 2022POM
1774 BRU16122119NP Actimax 500 tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 21 March 2017 till
20 March 2022GSL (10’s x 15,
10’s x 50 )1775 BRU16122120NP Betadine® Dry Powder Spray
2.5%
Povidone –Iodine 2.5% Mundipharma Pharmaceuticals
Limited, Cyprus
Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till
20 March 2022GSL
1776 BRU16122121P Flanil Analgesic Cream Methyl Salicylate 10.20% w/w,
Menthol 5.44% w/w and
Eugenol1.36% w/w
Biolab Company Ltd., Thailand Hongkiat Trading & Co. 21 March 2017 till
20 March 2022GSL
1777 BRU16122122NP Betadine® Antiseptic Skin
Cleanser 7.5% w/v
Povidone-Iodine 7.5% w/v PT Mahakam Beta Farma,
Indonesia
Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till
20 March 2022GSL
1778 BRU16122123P Oxynorm Sterile Solution for
Injection or Infusion 10mg/mL
Oxycodone hydrochloride 10mg/ml
(equivalent to 9 mg/ml
Oxycodone)
Hamol Ltd, United Kingdom Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till
20 March 2022POM
1779 BRU16122124P Ferriprox 500mg Tablet Deferiprone 500mg Apotex Inc., Canada Medicare 21 March 2017 till
20 March 2022POM
1780 BRU16122125P Vaxcel Lignocaine 2% Injection Lignocaine Hydrochloride 2%
(200mg/10ml)
Kotra Pharma (M) Sdn.
Bhd.,Malaysia
Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022POM
1781 BRU16122126P Oxynorm Oral Solution
5mg/5mL
Each 5ml contains oxycodone base
4.5mg as oxycodone hydrochloride
5mg
Mundipharma Pharmaceuticals
Limited, Cyprus
Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till
20 March 2022POM
1782 BRU16122127P Shintamet Film Coated Tablet
200mg
Cimetidine 200mg Y.S.P. Industries (M) Sdn. Bhd.,
Malaysia
Asterix United (B) Sdn. Bhd. 21 March 2017 till
20 March 2022POM
1783 BRU17012128P Zaltrap™
Concentrate for Solution for
Infusion 25mg/ml (4ml
vial)
Aflibercept 25mg/ml Sanofi-Aventis Deutschland
GmbH,
Germany
Medipharm Sdn Bhd 21 March 2017 till
20 March 2022
POM
BDMCA/RMP/0319 Page 135 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1784 BRU17012129P Zaltrap™
Concentrate for Solution for
Infusion 25mg/ml (8ml
vial)
Aflibercept 25mg/ml Sanofi-Aventis Deutschland
GmbH,
Germany
Medipharm Sdn Bhd 21 March 2017 till
20 March 2022
POM
1785 BRU17012130PS2 Tarceva Tablet 100mg Erlotinib 100mg Roche SpA, Italy Hongkiat Trading & Co 21 March 2017 till
20 March 2022
POM
1786 BRU17012131PS2 Tarceva Tablet 150mg Erlotinib 150mg Roche SpA, Italy Hongkiat Trading & Co 21 March 2017 till
20 March 2022
POM
1787 BRU17012132P Apo-Gliclazide 30mr MR
tablet
Gliclazide 30mg Apotex Inc. Canada Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1788 BRU17012133P Glitrol Controlled Release
Capsules 30mg
Gliclazide
30mg
Inventia Healthcare Pte Ltd, India Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1789 BRU17012134NP Orregel Choline salicylate 8.70% w/w; and
Cetylpyridinium Chloride
0.10% w/w
HOE Pharmaceuticals Sdn. Bhd.,
Malaysia
G & H Trading Company 21 March 2017 till
20 March 2022
GSL
1790 BRU17012135P Gaviscon peppermint tablets Sodium alginate 250mg
Sodium bicarbonate 133.5mg
Calcium carbonate 80mg
Reckitt Benckiser Healthcare (UK)
Limited, Dansom Lane, East Yo
rkshire, Hull HU8
7DS, United Kingdom
Syarikat Aliaa Sdn Bhd 21 March 2017 till
20 March 2022
GSL
1791 BRU17012136NP Senokot tablet Sennoside B 7.5mg Reckitt Benckiser Healthcare (UK)
Ltd., UK
Zuellig Pharma (B) Sdn Bhd 21 March 2017 till
20 March 2022
GSL
1792 BRU17012137P Tussidex Forte Linctus Dextromethorphan hydrobromide
15mg/5ml
Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hong Kiat Tradin
g Co
21 March 2017 till
20 March 2022
POM
1793 BRU17012138P Floctil 250mg Capsule Azithromycin dihydrate eq. to
Azithromycin 250mg
Unison Laboratories Co. Ltd,
Thailand
Hong Kiat Trading Co 21 March 2017 till
20 March 2022
POM
1794 BRU17012139P Selegos 5mg Tablet Selegiline
Hydrochloride 5mg
Medochemie Ltd., Cyprus Hong Kiat Tradin
g Co
21 March 2017 till
20 March 2022
POM
1795 BRU17012140P Timolol-POS 0.5% Eye Drop Timolol maleate 6.84mg/ml Ursapharm Arzneimittel GmbH,
Germany
Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1796 BRU17012141P Metformin Tablet 500mg Metformin Hydrochloride 500mg Dynapharm (M) Sdn Bhd.,
Malaysia
Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1797 BRU17012142P Axcel Cinnarizine Tablet Cinnarizine 25mg Kotra Pharma (M) Sdn.
Bhd.,Malaysia
Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1798 BRU17012143NP UO Cream 100mg/g (10%) Carbonyldiamide (Urea)
100mg/g (10%)
Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd, 21 March 2017 till
20 March 2022
GSL
BDMCA/RMP/0319 Page 136 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1799 BRU17012144NP Axcel Vitalic Tablet Vitamin B1 (Thiamine) 100mg
Vitamin B6 (Pyridoxine) 200mg
Vitamin B12 (Cyanocobalamine)
200mcg
Kotra Pharma (M) Sdn.
Bhd.,Malaysia
Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
P
1800 BRU17012145P Iqnyde Tablet 50mg Sildenafil Citrate 70.25mg
equivalent to Sildenafil 50mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 21 March 2017 till
20 March 2022
POM
1801 BRU17022146P Azarga Eye Drops Suspension Brinzolamide 10mg/ml
Timolol maleate 5mg/ml
S.A. Alcon, Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 21 March 2017 till
20 March 2022POM
1802 BRU17022147P Pharmaniaga Dermasole
Cream 0.1% w/w
Betamethasone 17-valerate 0.1%
w/w
Pharmaniaga Manufacturing
Berhad, Malaysia
G&H Trading Co 21 March 2017 till
20 March 2022POM
1803 BRU17022148P Jardiance 10mg Film-coated
Tablet
Empagliflozin 10mg Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 21 March 2017 till
20 March 2022POM
1804 BRU17022149P Jardiance 25mg Film-coated
Tablet
Empagliflozin 25mg Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 21 March 2017 till
20 March 2022POM
1805 BRU17022152P Glumet DC Tablet 500mg Metformin hydrochloride 500mg Pharmaniaga Manufacturing
Berhad, Malaysia
G&H Trading Co 21 March 2017 till
20 March 2022POM
1806 BRU17022153P Targin Prolonged Release
Tablets 5mg/2.5mg
Each tablet contains:
4.5mg of oxycodone as 5mg
oxycodone hydrochloride
2.25mg of naloxone as 2.5mg
naloxone hydrochloride.
Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 21 March 2017 till
20 March 2022POM
1807 BRU17022154P Targin Prolonged Release
Tablets 10mg/5mg
Each tablet contains:
9mg of oxycodone as 10mg
oxycodone hydrochloride
4.5mg of naloxone as 5mg
naloxone hydrochloride.
Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 21 March 2017 till
20 March 2022POM
1808 BRU17022155P Targin Prolonged Release
Tablets 20mg/10mg
Each tablet contains:
18mg of oxycodone as 20mg
oxycodone hydrochloride
9mg of naloxone as 10mg naloxone
hydrochloride.
Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 21 March 2017 till
20 March 2022POM
1809 BRU17022156P Targin Prolonged Release
Tablets 40mg/20mg
Each tablet contains:
36mg of oxycodone as 40mg
oxycodone hydrochloride
18mg of naloxone as 20mg
naloxone hydrochloride.
Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 21 March 2017 till
20 March 2022POM
BDMCA/RMP/0319 Page 137 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1810 BRU17022157P Pristine Shampoo 2% w/w Ketoconazole 2% w/w Xepa-Soul Pattinson (Malaysia)
Sdn Bhd
Hongkiat Trading & Company 21 March 2017 till
20 March 2022POM
1811 BRU17022158NP Effervescent Mouthwash
Tablets
Thymol EP 0.77mg;
Menthol EP 1.87mg
JL Bragg Ltd, UK Hongkiat Trading & Company 21 March 2017 till
20 March 2022GSL
1812 BRU17022159P Salmol Expectorant Each 5ml contains:
Salbutamol Sulfate equivalent to
Salbutamol 1.0 mg;
Guaiphenesin 50.0 mg
Biolab Co., Ltd, Thailand Hongkiat Trading & Company 21 March 2017 till
20 March 2022POM
1813 BRU17022160P Acnotin 10 Capsule Isotretinoin 10mg Mega Lifesceinces Public Company
Limited, Thailand
G&H Trading Co 21 March 2017 till
20 March 2022POM
1814 BRU17022161P Acnotin 20 Capsule Isotretinoin 20mg Mega Lifesceinces Public Company
Limited, Thailand
G&H Trading Co 21 March 2017 till
20 March 2022POM
1815 BRU17022162P Ketobid Shampoo Ketoconazole 2% w/v SM Pharmaceuticals Sdn Bhd,
Malaysia
G&H Trading Co 21 March 2017 till
20 March 2022POM
1816 BRU17022163P Axcel Glucosamine-500 Tablet Crystalline Glucosamine Sulphate
Potassium Chloride 665mg
equivalent to Glucosamine
Sulphate 500mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 21 March 2017 till
20 March 2022GSL
1817 BRU17022164P Cef-4 1G Injection Ceftazidime (as pentahydrate) 1g Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn Bhd 21 March 2017 till
20 March 2022POM
1818 BRU17032165P Asthator 4mg Chewable
Tablet
Montelukast sodium 4.160mg eq.
to montelukast 4mg
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022 POM
1819 BRU17032166P Asthator 5mg Chewable
Tablet
Montelukast sodium 5.20mg eq. to
montelukast 5mg
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022 POM
1820 BRU17032167P Asthator 10mgTablet Montelukast sodium 10.40mg eq.
to montelukast 10mg
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022 POM
BDMCA/RMP/0319 Page 138 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1821 BRU17032168NP OLICLINOMEL N7-1000E
EMULSION FOR INFUSION
1000ml of the mixture contain:
20% Lipid emulsion compartment
(corresponding to 20g/100ml)
(200ml); 40% Glucose solution
compartment (corresponding to
40g/100ml) (400ml); 10% Amino
acid solution compartment
(corresponding to 10g/100ml)
(400ml) (For Detailed Formulation
referred to Dossier)
Baxter S.A., Belgium Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1822 BRU17032169P PHARMANIAGA ZICONAL
CREAM 2% W/W
Ketoconazole 2.0% w/w Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Co 11 July 2017 till 10 July 2022 POM
1823 BRU17032170P Zolennic Concentrate for
Solution for IV Infusion
Each vial (5ml) contains Zoledronic
acid monohydrate equivalent to
Zoledronic acid anhydrous 4mg
Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022 POM
1824 BRU17032171P Dynadryl Syrup Each 5ml contains:
Diphenhydramine Hydrochloride
14mg; Sodium Citrate 57mg;
Ammonium Chloride 135mg
Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM
1825 BRU17032172P Depo Geston Injection
50mg/ml
Medroxyprogesterone Acetate
50mg/ml
PT. Triyasa Nagamas Farma,
Indonesia
Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM
1826 BRU17032173P Axcel Valacyclovir-500 Tablet Valacyclovir Hydrochloride
equivalent to Valacyclovir 500mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM
1827 BRU17032174P Lidocaine Hydrochloride 2%
w/v Injection
Lidocaine Hydrochloride 2% w/v
(200mg/10mL)
Pharmaniaga LifeScience Sdn.
Bhd.,
G & H Trading Co 11 July 2017 till 10 July 2022 POM
1828 BRU17032175NP Axcel Paracetamol-250
Suspension (Strawberry)
Paracetamol 250mg/5mL Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 GSL
BDMCA/RMP/0319 Page 139 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1829 BRU17042176NP OLICLINOMEL N4-550E
EMULSION FOR INFUSION
1000ml of the mixture contain:
20% Lipid emulsion compartment
(corresponding to 20g/100ml)
(200ml); 40% Glucose solution
compartment (corresponding to
40g/100ml) (400ml); 10% Amino
acid solution compartment
(corresponding to 10g/100ml)
(400ml) (For Detailed Formulation
referred to Dossier)
Baxter S.A., Belgium Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1830 BRU17042177NP HUACHI ENEMA Each 20ml enema contains:
Glycerin 30% w/v 6g;
Sodium Chloride 15% w/v 3g
Jen Sheng Pharmaceutical Co. Ltd.,
Taiwan
Yuh Hua Trading Company 11 July 2017 till 10 July 2022 GSL
1831 BRU17042178P Anexate Injection 0.5mg/5ml Flumazenil 0.5mg Cenexi SAS, France Medicare 11 July 2017 till 10 July 2022 POM
1832 BRU17042179P Glumet XR Tablet 500mg Metformin Hydrochloride DC
Granules 577.36mg (equivalent to
Metformin Hydrochloride 500mg)
Pharmaniaga manufacturing
Berhad, Malaysia
G & H Trading Co 11 July 2017 till 10 July 2022 POM
1833 BRU17042180NP POVIL ANTACID MIXTURE Each 10ml contains:
Dried Aluminium Hydroxide
…400mg
Magnesium
Hydroxide………..400mg
Winwa Medical Sdn Bhd, Pulau
Pinang, Malaysia
Yuh Hua Trading Company 11 July 2017 till 10 July 2022 GSL
1834 BRU17042181P Zimmex 20 Tablet Simvastatin 20mg Silom Medical Co Ltd, Thailand Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM
1835 BRU17042182P KOP 2.5% Gel (Ketoprofen BP) Ketoprofen 2.5% w/w Square Pharmaceuticals Ltd.,
Bangladesh
Hongkiat Trading & Company 11 July 2017 till 10 July 2022 P
1836 BRU17042183P Dextracin Eye/Ear Drops 1. Dexamethasone Sodium
Phosphate eq. to Dexamethasone
Phosphate 0.1% w/v
2. Neomycin Sulphate 0.5% w/v
Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM
BDMCA/RMP/0319 Page 140 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1837 BRU17042184P TRIPLIXAM
2.5MG/0.625MG/5MG FILM-
COATED TABLETS
Perindopril arginine 2.5mg
(corresponding to 1.6975mg of
perindopril)
Indapamide 0.625mg
Amlodipine besilate 6.935mg
(corresponding to 5mg of
amlodipine)
Servier (Ireland) Industries Ltd,
Ireland
Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1838 BRU17042185P TRIPLIXAM
5MG/1.25MG/5MG FILM-
COATED TABLETS
Perindopril arginine 5mg
(corresponding to 3.395mg of
perindopril)
Indapamide 1.25mg
Amlodipine besilate 6.935mg
(corresponding to 5mg of
amlodipine)
Servier (Ireland) Industries Ltd,
Ireland
Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1839 BRU17042186P TRIPLIXAM
5MG/1.25MG/10MG FILM-
COATED TABLETS
Perindopril arginine 5mg
(corresponding to 3.395mg of
perindopril)
Indapamide 1.25mg
Amlodipine besilate 13.870mg
(corresponding to 10mg of
amlodipine)
Servier (Ireland) Industries Ltd,
Ireland
Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1840 BRU17042187P TRIPLIXAM
10MG/2.5MG/5MG FILM-
COATED TABLETS
Perindopril arginine 10mg
(corresponding to 6.79mg of
perindopril)
Indapamide 2.5mg
Amlodipine besilate 6.935mg
(corresponding to 5mg of
amlodipine)
Servier (Ireland) Industries Ltd,
Ireland
Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1841 BRU17042188P TRIPLIXAM
10MG/2.5MG/10MG FILM-
COATED TABLETS
Perindopril arginine 10mg
(corresponding to 6.79mg of
perindopril)
Indapamide 2.5mg
Amlodipine besilate 13.870mg
(corresponding to 10mg of
amlodipine)
Servier (Ireland) Industries Ltd,
Ireland
Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1842 BRU17042189P Cotren Vaginal Tablet 500mg Clotrimazole 500mg Biolab Company Ltd., Thailand Hongkiat Trading & Company 11 July 2017 till 10 July 2022 P
1843 BRU17042190P Axcel Bromhexine Tablet Bromhexine Hydrochloride 8mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM
BDMCA/RMP/0319 Page 141 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1844 BRU17042191P Ameket Injection 2mL Ranitidine Hydrochloride eq. to
Ranitidine 25mg/ml
SM Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Co 11 July 2017 till 10 July 2022 POM
1845 BRU17042192P Zocol 150mg Capsule Fluconazole 150mg SM Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Co 11 July 2017 till 10 July 2022 POM
1846 BRU17042193NP Anucare Ointment Each g contains Zinc Oxide
107.5mg (10.75% w/w); Peru
Balsam 18.8mg (1.88% w/w);
Benzyl Benzoate 12.5mg (1.25%
w/w)
Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 11 July 2017 till 10 July 2022 GSL
1847 BRU17052194P Rani 150mg Effervescent
Granules
Ranitidine HCl (equivalent to
Ranitidine 150mg)
Techno Pharma Egypt, Egypt K-Seri Pharma 11 July 2017 till 10 July 2022 POM
1848 BRU17052195P Pamorelin 3.75mg Powder for
Suspension for Injection
Triptorelin (peptide base)
3.75mg equivalent
to triptorelin embonate
Debiopharm Research and
Manufacturing SA, Switzerland
Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM
1849 BRU17052196P Pamorelin 11.25mg Powder
for Suspension for Injection
Triptorelin (peptide base)
11.25mg equivalent
to triptorelin embonate
Debiopharm Research and
Manufacturing SA, Switzerland
Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM
1850 BRU17052197P Pamorelin 22.5mg Powder for
Suspension for Injection
Triptorelin (peptide base)
22.
5mg equivalent
to triptorelin embonate
Debiopharm Research and
Manufacturing SA, Switzerland
Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM
1851 BRU17052198NP Weng Heng Tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 11 July 2017 till 10 July 2022 GSL
1852 BRU17052199P MST CONTINUS 10MG
PROLONGED RELEASE
TABLETS
10mg
Morphine sulphate
Ph.Eur
Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1853 BRU17052200P MST CONTINUS 30MG
PROLONGED RELEASE
TABLETS
Morphine sulphate 30mg Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1854 BRU17052202P Viekirax 12.5mg/75mg/50mg
Tablets
Ombitasvir - 12.5mg (In the form
of Ombitasvir Extrudate)
Ritonavir - 50mg (In the form of
Ritonavir Extrudate)
Paritaprevir - 75mg (In the form of
Paritaprevir Extrudate)
Fournier Laboratories Ireland
Limited, Ireland
Zuellig Pharma (B) Sdn Bhd
Sdn Bhd
11 July 2017 till 10 July 2022 POM
1855 BRU17052203P Maxiclear Sinus & Pain Relief
Tablet 500mg/5mg
Paracetamol 500mg and
phenylephrine hydrochloride 5mg
Sigma Laboratories Ltd, India Medipharm Sdn Bhd 11 July 2017 till 10 July 2022 P
BDMCA/RMP/0319 Page 142 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1856 BRU17052204P Oxair Chewable Tablet 5mg Montelukast sodium 5.2mg (eq. to
Montelukast 5mg)
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM
1857 BRU17052205P Anacaine Injection 1% Lidocaine
Hydrochloride 1%
SM Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 11 July 2017 till 10 July 2022 POM
1858 BRU17052206P Anacaine Injection 2% Lidocaine
Hydrochloride 2
%
SM Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 11 July 2017 till 10 July 2022 POM
1859 BRU17052207NP Ferromed Tablet 200mg Ferrous Fumarate BP 200mg SM Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 11 July 2017 till 10 July 2022 GSL
1860 BRU17052208NP Calazite Lotion Calamine 15%w/v; Zinc oxide
5%w/v
Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 GSL
1861 BRU17052209P Acipan Injection 1mg/ml (1ml
ampoule)
Atropine Sulphate
1mg/ml
Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma 11 July 2017 till 10 July 2022 POM
1862 BRU17062210NP OLICLINOMEL N7-1000
EMULSION FOR INFUSION
1000ml of the mixture contain:
20% Lipid emulsion compartment
(corresponding to 20g/100ml)
(200ml); 40% Glucose solution
compartment (corresponding to
40g/100ml) (400ml); 10% Amino
acid solution compartment
(corresponding to 10g/100ml)
(400ml) (For Detailed Formulation
referred to Dossier)
Baxter S.A., Belgium Zuellig Pharma (B) Sdn Bhd
Sdn Bhd
11 July 2017 till 10 July 2022 POM
1863 BRU17062211P HYOSCINE BUTYLBROMIDE
TABLET
Hyoscine N-butylbromide 10mg Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 11 July 2017 till 10 July 2022 POM
1864 BRU17062212NP SMOFKABIVEN Emulsion for
Infusion
1000 ml of the mixture contain:
10% Amino acid solution with
electrolytes compartment
(corresponding to 10g/100ml)
(508ml); 42% Glucose
compartment (corresponding to
42g/100ml) (302ml); Lipid
emulsion compartment
(190ml);(For Detailed Formulation
referred to Dossier)
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd
Sdn Bhd
11 July 2017 till 10 July 2022 POM
BDMCA/RMP/0319 Page 143 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1865 BRU17062213P Cosentyx 150mg Powder for
Solution for Injection
Secukinumab 150mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd
Sdn Bhd
11 July 2017 till 10 July 2022 POM
1866 BRU17062214P Cosentyx 150mg Solution for
Injection in Pre-filled Syringe
Secukinumab 150mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd
Sdn Bhd
11 July 2017 till 10 July 2022 POM
1867 BRU17062215P Cosentyx 150mg Solution for
Injection in Pre-filled Pen
Secukinumab 150mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd
Sdn Bhd
11 July 2017 till 10 July 2022 POM
1868 BRU17062216P Morphine-Hameln 10mg/ml
Injection, 1mL
Morphine Sulphate 10mg/ml Hameln Pharmaceuticals GmbH,
Germany
Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM
1869 BRU17062217P XTANDI SOFT CAPSULES
40MG
Enzalutamide 40mg Catalent Pharma Solutions LLC,
USA
MediPharm Sdn Bhd 11 July 2017 till 10 July 2022 POM
1870 BRU17062218P PRAXBIND Solution for
Injection/Infusion 50mg/ml
Idarucizumab 50mg/ml Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM
1871 BRU17062219NP Zam-Buk Ointment Each 100g contains: Eucalyptus oil
5.02g; Camphor 1.76g
Interthai Pharmaceutical
Manufacturing Ltd, Thailand.
Zuellig Pharma (B) Sdn Bhd
Sdn Bhd
11 July 2017 till 10 July 2022 GSL
1872 BRU17062220P Axcel Sildenafil-100mg Tablet Sildenafil Citrate equivalent to
Sildenafil 100mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM
1873 BRU17062221NP Hialid 0.3% Ophthalmic
Solution
Purified Sodium Hyaluronate 0.3% Santen Pharmaceutical Co., Ltd.,
Japan
MediPharm Sdn Bhd 11 July 2017 till 10 July 2022 POM
1874 BRU17062222NP Hialid 0.1% Ophthalmic
Solution
Purified Sodium Hyaluronate 0.1% Santen Pharmaceutical Co., Ltd.,
Japan
MediPharm Sdn Bhd 11 July 2017 till 10 July 2022 GSL
1875 BRU17072223P Monoclox 500mg Powder for
Solution for Injection or
Infusion
Cloxacillin sodium equivalent to
cloxacillin 500mg
Medochemie Ltd., Cyprus Medicorp Sdn Bhd 03 October 2017 till 02
October 2022
POM
1876 BRU17072224P Simvor Tablets 10mg Simvastatin 10mg Ranbaxy (Malaysia) Sdn Bhd.,
Malaysia
Medipharm Sdn Bhd 03 October 2017 till 02
October 2022
POM
1877 BRU17072225P Gluvecron MR 30mg Tablet Gliclazide 30mg China Chemical & Pharmaceutical
Co. Ltd., Taiwan
Medicorp Sdn Bhd 03 October 2017 till 02
October 2022
POM
BDMCA/RMP/0319 Page 144 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1878 BRU17072226NP Restors Oral Powder i)Sodium Chloride BP 520mg
ii)Potassium Chloride BP 300mg
iii) Trisodium Citrate Dihydrate BP
580mg
iv) Glucose Anhydrous BP 2700mg
Winwa medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 03 October 2017 till 02
October 2022
GSL
1879 BRU17072227P Flumazenil-Hameln 0.1mg/ml
injection
Flumazenil 0.1mg/ml Hameln Pharmaceuticals GmbH,
Germany
Medicorp Sdn Bhd 03 October 2017 till 02
October 2022
POM
1880 BRU17072228P Oxycontin® Controlled-
Release Tablets 10mg
Oxycodone hydrochloride 10mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1881 BRU17072229P Oxycontin® Controlled-
Release Tablets 20mg
Oxycodone hydrochloride 20mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1882 BRU17072230P Oxycontin® Controlled-
Release Tablets 40mg
Oxycodone hydrochloride 40mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1883 BRU17072231P Oxycontin® Controlled-
Release Tablets 80mg
Oxycodone hydrochloride 80mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1884 BRU17082232P Xeljanz Film-Coated Tablet
5mg
Tofacitinib (as citrate) 5mg Pfizer Maufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1885 BRU17082233P Amoxicap 250 capsule Amoxicillin (as trihydrate 287mg)
250mg
Hovid Bhd., Malaysia G&H Trading Company 03 October 2017 till 02
October 2022
POM
1886 BRU17082234P Forxiga 5mg Film-Coated
Tablet
Dapagliflozin 5mg AstraZeneca Pharmaceuticals LP,
USA
Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1887 BRU17082235P Forxiga 10mg Film-Coated
Tablet
Dapagliflozin 10mg AstraZeneca Pharmaceuticals LP,
USA
Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1888 BRU17082236P Motigut Suspension 1ml/1ml Domperidone 1mg/ml Square Pharmaceuticals Ltd,
Bangladesh
Hongkiat Trading Co 03 October 2017 till 02
October 2022
POM
1889 BRU17082237P Tanzaril Tablet 50mg Losartan Potassium 50mg Silom Medical Co. Ltd, Thailand Medicorp Sdn Bhd 03 October 2017 till 02
October 2022
POM
1890 BRU17082238P Maxiclear Sinus Relief Tablet
10mg
Phenylephrine hydrochloride 10mg Sigma Laboratories Ltd, India Medipharm Sdn Bhd 03 October 2017 till 02
October 2022
P
1891 BRU17082239P Shrizine Injection 25mg/ml Fluphenazine Decanoate BP
25mg/ml
SM Pharmaceuticals Sdn Bhd,
Malaysia
G&H Trading Company 03 October 2017 till 02
October 2022
POM
1892 BRU17082240P Canesten HC Cream Clotrimazole 1% w/w;
Hydrocortisone 1% w/w
Kern Pharma S.L., Spain Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1893 BRU17082241P HOE’s Milk Of Magnesia Oral
Suspension 800mg/5ml
Magnesium Hydroxide 800mg/5ml HOE Pharmaceuticals Sdn Bhd,
Malaysia
G&H Trading Company 03 October 2017 till 02
October 2022
GSL
BDMCA/RMP/0319 Page 145 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1894 BRU17082242P Losartan Hexal 50mg film-
coated tablets
Losartan potassium 50mg
equivalent to Losartan 45.76mg
Sandoz IIAC Sanayi ve Ticaret A.S.,
Turkey
Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1895 BRU17082243P Losartan Hexal 100mg film-
coated tablets
Losartan potassium 100mg
equivalent to Losartan 91.52mg
Sandoz IIAC Sanayi ve Ticaret A.S.,
Turkey
Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1896 BRU17092244P RELVAR ELLIPTA 100/25
MICROGRAMS INHALATION
POWDER, PRE-DISPENSED
Pre-dispensed dose of
100micrograms of fluticasone
furoate and 25 micrograms of
vilanterol (as trifenatate).
*Each inhalation of the product
provides a delivered dose of 92mcg
of fluticasone furoate and 22mcg
of vilanterol (trifenatate)
Glaxo Operations UK Ltd (trading
as Glaxo Wellcome Operations),
UK
Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1897 BRU17092245P RELVAR ELLIPTA 200/25
MICROGRAMS INHALATION
POWDER, PRE-DISPENSED
Pre-dispensed dose of
200micrograms of fluticasone
furoate and 25 micrograms of
vilanterol (as trifenatate).
*Each inhalation of the product
provides a delivered dose of
184mcg of fluticasone furoate and
22mcg of vilanterol (trifenatate)
Glaxo Operations UK Ltd (trading
as Glaxo Wellcome Operations),
UK
Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02
October 2022
POM
1898 BRU17092246P HIPROGIN INJECTION
250MG/ML (1 ML AMPOULE)
Hydroxyprogesterone caproate
250mg/ml
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading Co 03 October 2017 till 02
October 2022
POM
1899 BRU17092247P Phebra Magnesium Sulfate
Heptahydrate 50% 2.5g/5mL
Magnesium Sulfate Heptahydrate
500mg/Ml
Phebra Pty Ltd, Australia G&H trading Co 03 October 2017 till 02
October 2022
POM
1900 BRU17092248P Phebra Magnesium Sulfate
Heptahydrate 50% 5g/10mL
Magnesium Sulfate Heptahydrate
500mg/Ml
Phebra Pty Ltd, Australia G&H Trading Co 03 October 2017 till 02
October 2022
POM
1901 BRU17092249NP Yellow Balsem Three Legs
Brand Ointment
Methylsalicylate 13.5% w/w
Menthol 7.5% w/w
Camphor 7% w/w
Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 03 October 2017 till 02
October 2022
GSL
BDMCA/RMP/0319 Page 146 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1902 BRU17092251NP ORS PLUS Each sachet contains the
equivalent of:
Sodium chloride 650 mg
Potassium chloride 375 mg
Trisodium citrate 725 mg
Glucose Anhydrous 3.375 g
Pharmaniaga Manufacturing
Berhad, Malaysia
G&H Trading Company 03 October 2017 till 02
October 2022
GSL
1903 BRU17092252NP Axe Brand Universal Oil i) Menthol crystals 20% w/w
ii) Camphor 5% w/w
iii) Eucalyptus Oil 15% w/w
iv) Methyl salicylate 15% w/w
Leung Kai Fook Medical Co Pte
Ltd., Singapore
Yuh Hua Trading Company 03 October 2017 till 02
October 2022
GSL
1904 BRU17092253NP Vitabiotics Pregnacare breast-
feeding Tablet/Capsule
Vitamins & Minerals; Omega-3 Fish
Oil (For detailed formulation
referred to dossier)
Tablets:
Thompson and Capper, UK
Capsule:
EuroCaps Limited, UK
Rico Agencies 03 October 2017 till 02
October 2022
GSL
1905 BRU17092254P Ravimed Tablet 5mg Medroxyprogesterone acetate USP
5mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 03 October 2017 till 02
October 2022
POM
1906 BRU17092255P Prazosin 2mg Tablet Prazosin HCl 2.190mg equivalent
to Prazosin 2mg
T.O. Pharma Co., Ltd., Thailand Medicorp Sdn Bhd 03 October 2017 till 02
October 2022
POM
1907 BRU17092256P Vaxcel Acyclovir 250mg I.V.
for Infusion
Acyclovir Sodium equivalent to
Acyclovir 250mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 03 October 2017 till 02
October 2022
POM
1908 BRU17112257P Azithromycin Tablets 250mg Azithromycin Dihydrate equivalent
to Azithromycin 250mg
Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26
February 2023
POM
1909 BRU17112258P Fybogel Orange Sachet Ispaghula Husk BP 3.5g Reckitt Benckiser Healthcare (UK)
Ltd., UK
Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26
February 2023
GSL
1910 BRU17112259NP Paracetamol Osteo-Tab
Modified Release Tablets
Paracetamol 665mg Macleods Pharmaceuticals Ltd,
India
Medipharm Sdn Bhd 27 February 2018 till 26
February 2023
P
BDMCA/RMP/0319 Page 147 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1911 BRU17112260P Phenadryl Syrup Each 5ml contains:
i) Diphenhydramine Hydrochloride
14mg
ii) Ammonium Chloride
135mg
iii) Sodium Citrate
57.5mg
Y.S.P. Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 27 February 2018 till 26
February 2023
POM
1912 BRU17112261P Dermosone Cream 0.1% Betamethasone (as Valerate) 0.1%
w/w
Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2018 till 26
February 2023
POM
1913 BRU17112262P Regpara® TABLETS 25MG Cinacalcet hydrochloride 27.55mg
eqv to Cinacalcet 25mg
Ohara Pharmaceutical Co., Japan K-Seri Pharma Sdn Bhd 27 February 2018 till 26
February 2023
POM
1914 BRU17112263PS1 &
BRU17112263PS2
Octagam 2.5g in 50ml Human Normal Immunoglobulin
(IVIg)* 50mg/ml
*corresponding to the total protein
content of which at least 95% is
human Immunoglobulin G
1. Octapharma S.A.S., 72 rue du
Marêchal Foch 67380 Lingolsheim,
France (Manufacturing, packaging,
batch release, storage and
distribution)
2. Octapharma Pharmazeutika
Produktionsges.m.b.H, Oberlaaer
Straβe 235 1100 Vienna, Austria
(Manufacturing, packaging testing,
batch certification)
3. Octapharma GmbH,
Niederlassung Dessau, Otto-
Reuter- Straβe 3, Gemaβ den
Lageplanen Nr. 1 bis Nr. 3, 06847
Dessau-Roβlau, Saxony-Anhalt,
Germany (Additional packaging
site)
G&H Trading Sdn Bhd 27 February 2018 till 26
February 2023
POM
1915 BRU17122264P Ceficad 1000mg injection Cefepime Hydrochloride USP eq to
Cefepime 1000mg
Cadila Pharmaceuticals Limited,
India
K-Seri Pharma 27 February 2018 till 26
February 2023
POM
1916 BRU17122265P Probitor capsule 20mg Omeprazole 20mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma Sdn Bhd 27 February 2018 till 26
February 2023
POM
1917 BRU17122266P Solbid tablet 10mg Isosorbide Dinitrate 10mg SM Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 27 February 2018 till 26
February 2023
POM
BDMCA/RMP/0319 Page 148 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1918 BRU17122267NP Adelim Ringworm Solution Tolnaftate 1% w/v Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 27 February 2018 till 26
February 2023
GSL
1919 BRU17122268P Converium 300mg Tablet Irbesartan 300mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 27 February 2018 till 26
February 2023
POM
1920 BRU17122269P Salazine Enteric Coated Tablet
500mg
Sulfasalazine 500mg Sriprasit Pharma Co. Ltd., Thailand Medicorp Sdn Bhd 27 February 2018 till 26
February 2023
POM
1921 BRU17122270P Axcel Metronidazole-200
Tablet
Metronidazole 200mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 27 February 2018 till 26
February 2023
POM
1922 BRU17122271NP Dermorub Liniment Muscle &
Joint
Methyl salicylate 25% v/v Winwa Medical Sdn. Bhd.,
Malaysia
Medicorp Sdn Bhd 27 February 2018 till 26
February 2023
GSL
1923 BRU17122272P Tenof 300mg tablet Tenofovir Disoproxil Fumarate
300mg eq. to Tenofovir Disoproxil
245mg
Hetero Labs Limited,India K-Seri Pharma Sdn Bhd 27 February 2018 till 26
February 2023
POM
1924 BRU17122273NP Bisacodyl Tablets 5mg Bisacodyl 5mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 27 February 2018 till 26
February 2023
P (as discussed in
the Meeting). All
Bisacodyl tablet
to change from
POM to P. If
already GSL
retain as GSL
(refer to minute
of 119th Mtg
Item 4.1 & 26TH
BDMCA Mtg
1925 BRU17122274P Alfutor ER Tablets 10mg Alfuzosin Hydrochloride 10mg Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 27 February 2018 till 26
February 2023
POM
1926 BRU17122275P Venlift ER 37.5mg Capsule Venlafaxine Hydrochloride
equivalent to Venlafaxine 37.5mg
Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 27 February 2018 till 26
February 2023
POM
1927 BRU17122276P Venlift ER 75mg Capsule Venlafaxine Hydrochloride
equivalent to Venlafaxine 75mg
Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 27 February 2018 till 26
February 2023
POM
1928 BRU17122277P Venlift ER 150mg Capsule Venlafaxine Hydrochloride
equivalent to Venlafaxine 150mg
Torrent Pharmaceuticals Ltd.,
India
K-Seri Pharma Sdn Bhd 27 February 2018 till 26
February 2023
POM
BDMCA/RMP/0319 Page 149 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1929 BRU17122278NP Rohto C Cube Eye Drops Per 100mL contains: Potassium
Chloride 0.08g; Sodium Chloride
0.44g; Hydroxyethylcellulose 0.07g
Rohto Pharmaceutical Co., Ltd.,
Japan
Hamitan Marketing 27 February 2018 till 26
February 2023
GSL
1930 BRU17122279P Medaxonum (Ceftriaxone) 1G
Powder for Injection for
Infusion
Ceftriaxone sodium eq. to
ceftriaxone 1G
Medochemie Ltd., Cyprus Medicorp Sdn Bhd 27 February 2018 till 26
February 2023
POM
1931 BRU17122281NP Konsyl Original Formula
Psyllium Fiber
Psyllium Hydrophilic Mucilloid
Husk 6g/dose
Konsyl Pharmaceuticals, Inc., USA MediPharm Sdn Bhd 27 February 2018 till 26
February 2023
GSL
1932 BRU17122282P VAXCEL CEFOBACTAM-1G
INJECTION
Cefoperazone sodium eq. to
cefoperazone 500mg; Sulbactam
sodium eq. to Sulbactam 500mg
Kotra Pharma (M) Sdn Bhd.,
Malaysia
Medicorp Sdn Bhd 27 February 2018 till 26
February 2023
POM
1933 BRU17122283P Ibuspan Tablet 200mg Ibuprofen 200mg SM Pharmacetuicals Sdn Bhd,
Malaysia
G & H Trading Company 27 February 2018 till 26
February 2023
P
1934 BRU17122284NP Ubat Sembelit Cap Kaki Tiga Per 5ml: Magnesium sulphate
1.77g
Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 27 February 2018 till 26
February 2023
GSL
1935 BRU17122285P Fucithalmic Eye Drops 1% Fusidic acid 10mg/g LEO Laboratories Limited, Ireland LF Asia (Borneo) Sdn Bhd 27 February 2018 till 26
February 2023
POM
1936 BRU17122286NP Calamine Lotion BP 15% w/v i) Calamine 15%w/v; ii) Zinc
Oxide 5% w/v
SM Pharmacetuicals Sdn Bhd,
Malaysia
G & H Trading Company 27 February 2018 till 26
February 2023
GSL
1937 BRU17122287P Pivakan 0.5% w/v (plain)
Injection (20ml Vial)
Bupivacaine HCl Monohydrate
equivalent to Bupivacaine HCl
5mg/ml
Duophrma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 27 February 2018 till 26
February 2023
POM
1938 BRU18012288P Irbesartan Tablets 150mg Irbesartan 150mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26
February 2023
POM
1939 BRU18012289P Irbesartan Tablets 300mg Irbesartan 300mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26
February 2023
POM
1940 BRU18012290P Travocort Cream Isoconazole nitrate (10mg/g):
Diflucortolone valerate (1mg/1g)
Bayer Healthcare Manufacturing
S.r.I, Italy
Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26
February 2023
POM
1941 BRU18012291P Spiolto Respimat Inhalation
Solution 2.5μg/2.5μg per
actuation
Per actuation: 2.5mg Tiotropium
(as bromide monohydrate) and
2.5mg Olodaterol (as
hydrochloride)
Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 27 February 2018 till 26
February 2023
POM
1942 BRU18012292P Zykadia™ 150mg Hard Capsule Ceritinib 150mg Novartis Pharma AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26
February 2023
POM
1943 BRU18012293P Synagis 100mg/ml Solution for
Injection
Palivizumab 100mg/ml Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26
February 2023
POM
BDMCA/RMP/0319 Page 150 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1944 BRU18012294NP Ketosteril Film-Coated Tablet Calcium-3-methyl-2-oxo-valerate
(α–Ketoanologue to Isoleucine,
calcium salt) 67 mg;
Calcium-4-methyl-2-oxo-valerate
(α–Ketoanologue to Leucine,
calcium salt) 101 mg;
Calcium-2--oxo-3-phenyl-
propionate (α–Ketoanologue to
Phenylalanine, calcium salt) 68 mg;
Calcium-3-methyl-2-oxo-butyrate
(α–Hydroxyanalogue to Valine,
calcium salt) 86 mg;
Calcium-DL-2-hydroxyl-4-(methyl-
thio)butyrate (α–Hydroxyanalogue
to Methionine, calcium salt) 59 mg;
L-Lysine acetate (= 75mg L-Lysine)
105 mg;
L-Threonine 53 mg;
L-Tryptophan 23 mg;
L-Histidine 38 mg;
L-Tyrosine 30 mg;
Labesfal-Laboratorios Almiro S.A.,
Portugal
Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26
February 2023
POM
1945 BRU18012295PS1;
BRU18012295PS2
Kadcyla Powder for
Coencentrate for Solution for
Infusion 100mg/vial
Trastuzumab emtansine 100mg Patheon, Manufacturing Services,
LLC, USA (S1); F. Hoffmann-La
Roche Ltd, Switzerland (S2)
MediPharm Sdn Bhd 27 February 2018 till 26
February 2023
POM
1946 BRU18012296PS1;
BRU18012296PS2
Kadcyla Powder for
Coencentrate for Solution for
Infusion 160mg/vial
Trastuzumab emtansine 160mg Patheon, Manufacturing Services,
LLC, USA (S1); F. Hoffmann-La
Roche Ltd, Switzerland (S2)
MediPharm Sdn Bhd 27 February 2018 till 26
February 2023
POM
1947 BRU18012297NP 5% DEXTROSE IN WATER
SOLUTION FOR INTRAVENOUS
INFUSION
Dextrose monohydrate 5% Euro-Med Laboratories Phil Inc,
Philippines
Medicorp Sdn Bhd 27 February 2018 till 26
February 2023
GSL
BDMCA/RMP/0319 Page 151 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1948 BRU18012298NP 10% DEXTROSE IN WATER
SOLUTION FOR INTRAVENOUS
INFUSION
Dextrose monohydrate 10% Euro-Med Laboratories Phil Inc,
Philippines
Medicorp Sdn Bhd 27 February 2018 till 26
February 2023
GSL
1949 BRU18012299P THREE LEGS TINEA-KARE ANTI-
FUNGAL CREAM 1%W/W
Clotrimazole 1% w/w Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 27 February 2018 till 26
February 2023
GSL
1950 BRU18012300P Airlukast Chewable Tablets
5mg
Montelukast sodium 5.187mg (eq.
to Montelukast 5mg)
Ranbaxy (Malaysia) Sdn Bhd,
Malaysia
MediPharm Sdn Bhd 27 February 2018 till 26
February 2023
POM
1951 BRU18012301NP Gascoal Tablet 50mg Dimethylpolysiloxane 50mg Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 27 February 2018 till 26
February 2023
GSL
BDMCA/RMP/0319 Page 152 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1952 BRU18012302NP Vitabiotics Pregnacare
Original Tablet
Natural Mixed Carotenoids (as
Natural Betacarotene 20% CWD
Powder 10.0 mg) 2.00 mg;
Thiamin (Vitamin B1) (as Thiamine
Mononitrate 3.7 mg) 3.00 mg;
Riboflavin (Vitamin B2) (as
Riboflavin 2.0 mg) 2.00 mg;
Vitamin D3 (as Vitamin D3 100
IU/mg EC 4.0 mg) 10.00 µg;
Folacin (Folic Acid) (as Folic Acid
400.0 µg) 400.00 µg;
Vitamin K (as Vitamin K1 5% GFT
(BASF) 1.4 mg) 70.00 µg;
Vitamin B12 (as Cyanocobalamin
0.1% DCP Prep. 6.0 mg) 6.00 µg;
Vitamin B6 (as Pyridoxine
Hydrochloride 12.2 mg) 10.00 mg;
Pantothenic Acid (as Calcium D-
Pantothenate 6.5 mg) 6.00 mg;
Biotin (as D-Biotin 150.0 µg)
150.00 µg;
Vitamin C (as Ascorbic Acid HPMC
(97%) 72.2 mg) 70.00 mg;
Vitamin E (as D alphaTocopheryl
Acid Succinate 24.6 mg) 20.00 mg;
Niacin (Vitamin B3) (as
Nicotinamide 20.0 mg) 20.00 mg;
Zinc (as Zinc Sulphate
Monohydrate 41.2 mg) 15.00 mg;
Iron (as Ferrous Fumarate 51.7 mg)
17.00 mg;
Brunel Healthcare Manufacturing
Limited, UK
Rico Agencies 27 February 2018 till 26
February 2023
GSL
1953 BRU18022303NP Glycophos Concentrate for
Solution for Infusion
Sodium glycerophosphate
pentahydrate 306.1mg/ml
corresponds to 216mg sodium
glycerophosphate
Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
P
BDMCA/RMP/0319 Page 153 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1954 BRU18022304NP Nutrilite Daily Tablet
Nutrilite concentrate 527.84mg;
Dicalcium phosphate 447.58mg;
Ascorbic acid 125.96mg; Ferrous
fumarate 57.37mg; d-alpha-
tocopheryl acid succinate 32.21mg;
Niacinamide 23.99mg; Zinc oxide
21.55mg; Copper gluconate
16.44mg; Calcium stearate
20.48mg; Corn starch 15.34mg;
Talc 15.00mg; D-calcium
panthothenate 13.88mg; Sucrose
13.12mg; Fish gelatin 10.80mg;
Sodium carboxymethylcellulose
10.39mg; Lactose 9.8mg;
Magnesium oxide 8.62mg;
Hydroxypropyl methylcellulose
8.01mg; PolyvInylpyrrolidone
5.28mg; Vitamin A Palmitate
5.00mg; Pyridoxine Hydrochloride
3.64mg; Riboflavin 2.99mg;
Thiamine mononitrate 2.79mg;
Glycerin 0.80mg; Folic acid 0.64mg;
Potassium iodide 0.27mg;
Carnauba wax 0.08mg; Vitamin D3
0.02mg ; Cyanocobalamin 0.002mg
Access Business Group LLC, USA Amway (B) Sdn Bhd 06 June 2018 till 05 June
2023
GSL
BDMCA/RMP/0319 Page 154 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1955 BRU18022305P Flutiform 50 microgram/5
microgram Per Actuation
Pressurised Inhalation
Suspension
Each metered dose (ex-valve)
contains:
50mcg of fluticasone propionate
and 5mcg of formeterol fumarate
dihydrate,
This is equivalent to a delivered
dose (ex-actuator) of
approximately 46 mcg of
fluticasone propionate/ 4.5mcg of
formoterol fumarate dihydrate.
Fisons Limited, UK Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1956 BRU18022306P Flutiform 250 microgram/10
microgram Per Actuation
Pressurised Inhalation
Suspension
Each metered dose (ex-valve)
contains:
250mcg of fluticasone propionate
and 10mcg of formeterol fumarate
dihydrate,
This is equivalent to a delivered
dose (ex-actuator) of
approximately 230 mcg of
fluticasone propionate/ 9.0mcg of
formoterol fumarate dihydrate.
Fisons Limited, UK Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
BDMCA/RMP/0319 Page 155 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1957 BRU18022307P Flutiform 125 microgram/5
microgram Per Actuation
Pressurised Inhalation
Suspension
Each metered dose (ex-valve)
contains:
125mcg of fluticasone propionate
and 5mcg of formeterol fumarate
dihydrate,
This is equivalent to a delivered
dose (ex-actuator) of
approximately 115 mcg of
fluticasone propionate/ 4.5mcg of
formoterol fumarate dihydrate.
Fisons Limited, UK Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1958 BRU18022308P Jakavi 10mg tablet Ruxolitinib phosphate 13.2mg eq.
to 10mg Ruxolitinib
Novartis Pharma Stein, AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1959 BRU18022309P HYDROCORTISONE INJECTION
100MG
Each vial contains Hydrocortisone
Sodium Succinate BP equivalent to
Hydrocortisone 100mg
SM Pharmaceuticals Sdn Bhd.,
Malaysia
G&H Trading Company 06 June 2018 till 05 June
2023
POM
1960 BRU18022310P Opsumit 10mg Film-coated
Tablet
Macitentan 10mg Patheon Italia S.p.A., Italy Medipharm Sdn Bhd 06 June 2018 till 05 June
2023
POM
1961 BRU18022311P URACTONUM 25MG TABLET Spironolactone 25mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 06 June 2018 till 05 June
2023
POM
1962 BRU18022312P Perjeta Concentrate for
Solution for Infusion
420mg/14ml
Pertuzumab 420mg Roche Diagnostics GmbH,
Germany
Medipharm Sdn Bhd 06 June 2018 till 05 June
2023
POM
1963 BRU18022313P Cefepime-AFT Powder for
Injection 1G
Cefepime Hydrochloride equivalent
to Cefepime 1G
Qilu Pharmaceutical Co. Ltd., P.R.
China
Medipharm Sdn Bhd 06 June 2018 till 05 June
2023
POM
BDMCA/RMP/0319 Page 156 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1964 BRU18022314NP Renal-Sol® A1 Each litre of concentrate contains:
Sodium Chloride BP 161.43g
Potassium Chloride BP 5.50g
Calcium Chloride 2H2O BP 9.74g
Magnesium Chloride 6H2O BP
3.74g
Glacial Acetic Acid BP 8.84g
Highly Purified Water BP 1000mL
Renal Laboratories Sdn Bhd,
Malaysia
K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June
2023
GSL
1965 BRU18022315NP Renal-Sol® A3 Each litre of concentrate contains:
Sodium Chloride BP 161.43g
Potassium Chloride BP 5.50g
Calcium Chloride 2H2O BP 6.75g
Magnesium Chloride 6H2O BP
3.74g
Glacial Acetic Acid BP 8.84g
Highly Purified Water BP 1000mL
Renal Laboratories Sdn Bhd,
Malaysia
K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June
2023
GSL
1966 BRU18022316P Celecoxib Sandoz Capsule
200mg
Celecoxib 200mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1967 BRU18022317NP Microshield® 2 Chlorhexidine
Skin Cleanser
Chlorhexidine Gluconate 2% w/v Ensign Laboratories Pty Ltd.,
Australia
Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
GSL
1968 BRU18022318NP Sangobion Capsule Each capsule contains:
Ferrous Gluconate 250mg
Manganese sulphate 0.2mg
Copper sulphate 0.2mg
Vitamin C 50.0mg
Folic acid 1.0mg
Vitamin B12 7.5mcg
PT. Merck Tbk, Indonesia Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
GSL
1969 BRU18022319P Talgesil Injection 0.1mg/2ml
(Amp)
Fentanyl 0.1mg/2ml Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June
2023
POM
BDMCA/RMP/0319 Page 157 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1970 BRU18032320P Norfox tablet Norfloxacin 400mg The United Drug (1996) Co. Ltd.,
Thailand
Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
POM
1971 BRU18032321P Domil Suspension 5mg/5ml Domperidone 5mg/5ml Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1972 BRU18032322P Latanostill 50mcg/ml Eye
Drops Solution
Latanoprost 50 mcg/ml Bruschettini s.r.I., Italy Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
POM
1973 BRU18032323P Gardasil 9, suspension for
injection
Each 0.5mL dose contains:
HPV Type 6 L1 Protein….. 30 μg
HPV Type 11 L1 Protein….40 μg
HPV Type 16 L1 Protei.…. 60 μg
HPV Type 18 L1 Protein….40 μg
HPV Type 31 L1 Protein.... 20 μg
HPV Type 33 L1 Protein… 20 μg
HPV Type 45 L1 Protein… 20 μg
HPV Type 52 L1 Protein… 20 μg
HPV Type 58 L1 Protein… 20 μg
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1974 BRU18032324P Entresto 50mg Film-coated
Tablets
Sacubitril 24.3 mg & Valsartan 25.7
mg
Novartis Singapore
Pharmaceutical Manufacturing Pte
Ltd, Singapore
Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1975 BRU18032325P Entresto 100mg Film-coated
Tablets
Sacubitril 48.6 mg & Valsartan 51.4
mg
Novartis Singapore
Pharmaceutical Manufacturing Pte
Ltd, Singapore
Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1976 BRU18032326P Entresto 200mg Film-coated
Tablets
Sacubitril 97.2 mg & Valsartan
102.8 mg
Novartis Singapore
Pharmaceutical Manufacturing Pte
Ltd, Singapore
Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1977 BRU18032327P Dyna Amoxycillin 125mg/5ml Amoxycillin (as trihydrate)
125mg/5ml
Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
POM
1978 BRU18032328P Winofen suspension 2% w/v Ibuprofen 100mg/5ml Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
P
1979 BRU18032329P Wincort 1% cream Hydrocortisone acetate 1% w/w Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
POM
1980 BRU18032330P Acugesic Tablet 50mg Tramadol HCl 50mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June
2023
POM
1981 BRU18032331NP Microshield® Handrub
Solution
Chlorhexidine Gluconate 0.5% w/v
in Ethanol 70% v/v
Ensign Laboratories Pty Ltd.,
Australia
Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
GSL
BDMCA/RMP/0319 Page 158 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1982 BRU18032332P Defuzin Cream 2% w/w Fusidic acid 2% w/w Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 June 2018 till 05 June
2023
POM
1983 BRU18032333P Hydrochlorzide-50 Tablet Hydrochlorothiazide 50mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 June 2018 till 05 June
2023
POM
1984 BRU18032334P SIMBRINZA* 10 mg/ml + 2
mg/ml eye drops, suspension
1 ml of suspension contains 10 mg
of Brinzolamide and 2 mg of
Brimonidine tartrate equivalent to
1.3 mg of Brimonidine
Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1985 BRU18032335NP Hexidin Cream 1% Chlorhexidine Gluconate 1% w/w Noripharma Sdn Bhd, Malaysia G&H Trading Company 06 June 2018 till 05 June
2023
GSL
1986 BRU18032336NP Green Balsem, Three Legs
Brand
Menthol........... 10% w/w
Camphor......... 4% w/w
Syarikat Wen Ken Drug Sdn Bhd.,
Malaysia
Syarikat Rajamas Bersama 06 June 2018 till 05 June
2023
GSL
1987 BRU18042337P DUAVIVE 20MG/0.45MG
MODIFIED-RELEASE TABLETS Bazedoxifene acetate equivalent to
20mg bazedoxifene; and
Conjugated estrogens 0.45mg.
Pfizer Ireland Pharmaceuticals,
Ireland
Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1988 BRU18042338P Novatretin™ 25mg Capsules Acitretin 25mg Micro-Sphere S.A., Switzerland K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June
2023
POM
1989 BRU18042339P Novatretin™ 10mg Capsules Acitretin 10mg Micro-Sphere S.A., Switzerland K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June
2023
POM
1990 BRU18042340P Axcel Metoclopramide Tablet Metoclopramide Hydrochloride
equivalent to Anhydrous
Metoclopramide Hydrochloride
10mg
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
POM
1991 BRU18042341P TADIM Colistimethate Sodium
1 Million IU Powder for
Nebuliser Solution Vial
Colistimethate Sodium 1 Million IU Xellia Pharmaceuticals ApS,
Denmark
G&H Trading Company 06 June 2018 till 05 June
2023
POM
1992 BRU18042342P Clovix 75mg tablet Clopidogrel hydrogen sulphate
97.875mg (eq. to clopidogrel
75mg)
China Chemical & Pharmaceutical
Co. Ltd., R.O.C., Taiwan
Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
POM
1993 BRU18042343P AXCEL CETIRIZINE TABLET Cetirizine dihydrochloride 10mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
P
BDMCA/RMP/0319 Page 159 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
1994 BRU18042344P Zarzio 30 MU/0.5ml Solution
for Injection or Infusion in Pre-
filled Syringe
30 million units (equivalent to
300mcg) filgrastim in 0.5ml
IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1995 BRU18042345P Ibrance Capsules 75mg Palbociclib 75mg Pfizer Manufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1996 BRU18042346P Ibrance Capsules 100mg Palbociclib 100mg Pfizer Manufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1997 BRU18042347P Ibrance Capsules 125mg Palbociclib 125mg Pfizer Manufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1998 BRU18042348P TULIP® 40MG FILM-COATED
TABLET
Atorvastatin (as Atorvastatin
calcium) 40mg
Lek Pharmaceuticals d.d , Solvenia Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
1999 BRU18062349P Victoza® 6mg/ml, Solution for
Injeciton in Pre-filled Pen
Liraglutide 6mg/ml Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June
2023
POM
2000 BRU18062350P AXCEL CLINDAMYCIN TOPICAL
SOLUTION 1% W/V
Clindamycin Phosphate 1% Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
POM
2001 BRU18062351P Flucon Solution for IV Infusion
2mg/ml
Fluconazole 2mg/ml Siu Guan Chem. Ind., Taiwan K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June
2023
POM
2002 BRU18062352P ANALPAN INJECTION
75MG/3ML
Diclofenac Sodium 75mg/3ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 June 2018 till 05 June
2023
POM
2003 BRU18062353P ELIGARD® Powder and Solvent
for Solution for Injection
7.5mg
Leuprorelin Acetate 7.5 mg
(equivalent to 6.96 mg leuprorelin)
(syringe B)
Solvent (Syringe A):
Poly(DL-lactic-co-glycolic-acid)
(50:50) and N-methylpyrrolidine
Tolmar Inc., USA Medipharm Sdn Bhd 06 June 2018 till 05 June
2023
POM
2004 BRU18062354P ELIGARD® Powder and Solvent
for Solution for Injection
22.5mg
Leuprorelin Acetate 22.5 mg
(equivalent to 20.87 mg
leuprorelin) (syringe B)
Solvent (Syringe A):
Poly(DL-lactic-co-glycolic-acid)
(75:25) and N-methylpyrrolidine
Tolmar Inc., USA Medipharm Sdn Bhd 06 June 2018 till 05 June
2023
POM
BDMCA/RMP/0319 Page 160 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2005 BRU18062355P ELIGARD® Powder and Solvent
for Solution for Injection
45mg
Leuprorelin Acetate 45 mg
(equivalent to 41.7 mg leuprorelin)
(syringe B)
Solvent (Syringe A):
Poly(DL-lactic-co-glycolic-acid)
(85:15) and N-methylpyrrolidine
Tolmar Inc., USA Medipharm Sdn Bhd 06 June 2018 till 05 June
2023
POM
2006 BRU18062356P THREE LEGS TINEA-KARE ANTI-
FUNGAL SPRAY 1% W/V
Clotrimazole 1% w/v Syarikat Wen Ken Drug Sdn. Bhd.,
Malaysia
Syarikat Rajamas Bersama 06 June 2018 till 05 June
2023
GSL
2007 BRU18062357NP Potrelease TR Tablet 600mg Potassium Chloride 600mg SM Pharmaceuticals Sdn Bhd.,
Malaysia
G&H Trading Company 06 June 2018 till 05 June
2023
P
2008 BRU18062358NP Renal-Sol® A3 + G Each litre of concentrate contains:
Sodium Chloride BP 161.43g
Potassium Chloride BP 5.50g
Calcium Chloride 2H2O BP 6.75g
Magnesium Chloride 6H2O BP
3.74g
Glacial Acetic Acid BP 8.84g
Dextrose H20 73.00g
Highly Purified Water BP 1000mL
Renal Laboratories Sdn Bhd,
Malaysia
K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June
2023
GSL
2009 BRU18062359P Encardil Tablet 10mg Enalapril Maleate 10mg SM Pharmaceuticals Sdn Bhd.,
Malaysia
G&H Trading Company 06 June 2018 till 05 June
2023
POM
2010 BRU18062360NP Microshield® 4 Chlorhexidine
Surgical Handwash
Chlorhexidine Gluconate 4% w/v
(equivalent to Chlorhexidine
22.5g/L)
Ensign Laboratories Pty Ltd.,
Australia
Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
GSL
2011 BRU18062361P Pharmaniaga Ranitidine
Tablet 150mg
Ranitidine (as hydrochloride)
150mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G&H Trading Company 06 June 2018 till 05 June
2023
POM
2012 BRU18062362P Apo-Carvedilol 6.25mg Tablet Carvedilol 6.25mg Apotex Inc, Canada Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
POM
2013 BRU18062363P Apo-Carvedilol 25mg Tablet Carvedilol 25mg Apotex Inc, Canada Medicorp Sdn Bhd 06 June 2018 till 05 June
2023
POM
BDMCA/RMP/0319 Page 161 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2014 BRU18062364P Cef-3 Injection IM (500mg) Powder - Ceftriaxone (as disodium)
500mg
Diluent – Lidocaine HCl 1%
Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn Bhd 05 September 2018 till 04
September 2023
POM
2015 BRU18062365P Simponi Solution for Injection
100mg/1.0ml
Golimumab 100mg/1.0ml Baxter Pharmaceutical Solutions
LLC, United States
Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04
September 2023
POM
2016 BRU18062366P Apo-Atorvastatin 20mg tablet Atorvastatin calcium propylene
glycol solvate USP 22mg eq. to
20mg atorvastatin
Apotex Inc., Canada Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
POM
2017 BRU18062367P Apo-Atorvastatin 40mg tablet Atorvastatin calcium propylene
glycol solvate USP 42mg eq. to
40mg atorvastatin
Apotex Inc., Canada Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
POM
2018 BRU18062368NP Sodium Chloride Parenteral
Solution 0.9%
Each 100ml contains Sodium
Chloride 900mg
Euro-Med Laboratories Phil.,
Philippines
Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
GSL
2019 BRU18062369NP Lactated Ringer’s Solution Each 100ml contains:
Sodium Chloride
600mg
Sodium Lactate Anhydrous
310mg
Potassium Chloride
30mg
Calcium Chloride Dihydrate
20mg
Euro-Med Laboratories Phil.,
Philippines
Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
GSL
2020 BRU18062370NP Optrex Refreshing Eye Drops Hamamelis Water (Witch Hazel)
13.0% v/v
Reckitt Beckinser Healthcare
International Ltd, UK
Syarikat Aliaa Sdn Bhd 05 September 2018 till 04
September 2023
GSL
2021 BRU18062371P Codipront Capsules Codeine base 30mg (as Codeine
phosphate hemihydrate);
Phenyltoloxamine base 10mg (as
Phenyltoloxamine citrate)
CTS Chemical Industries Ltd, Israel Hongkiat Trading & Company 05 September 2018 till 04
September 2023
POM
2022 BRU18062372PS1,
BRU18062372PS2 &
BRU18062372PS3
Mixtard® 30 Penfill® 100
IU/ml, 3ml Cartridge
Suspension for Injeciton
1ml suspension contains 100 IU
(3.5 mg) of insulin human (rDNA)
(30% as soluble insulin and 70% as
isophane insulin)
1. Novo Nordisk A/S, Denmark
(S1)
2. Novo Nordisk Production
SAS, France (S2)
3. Novo Nordisk Producão,
Brazil (S3)
Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04
September 2023
POM
BDMCA/RMP/0319 Page 162 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2023 BRU18072373P Apo-Ranitidine 150mg Tablet Ranitidine 150mg Apotex Inc, Canada MediPharm Sdn Bhd 05 September 2018 till 04
September 2023
POM
2024 BRU18072374P Axcel Iridin Linctus Pholcodine 10mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
POM
2025 BRU18072375P Dynalexin Dry Syrup
125mg/5ml
Cephalexin monohydrate 130mg
eq to 125mg cephalexin per 5ml
Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
POM
2026 BRU18072376P Aspira Tablet 10mg Montelukast sodium 10.40mg
equivalent to montelukast 10mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G&H Trading Company 05 September 2018 till 04
September 2023
POM
2027 BRU18072377P Terbin Cream 1% Terbinafine Hydrochloride 10mg/g SM Pharmaceuticals Sdn Bhd,
Malaysia
G&H Trading Company 05 September 2018 till 04
September 2023
GSL
2028 BRU18072378NP Eagle Brand Medicated Oil
Aromatic, Lavender &
Eucalyptus
i) Menthol 16.0%
w/w
ii) Methyl Salicylate 35.0%
w/w
iii) Eucalyptus Oil 17.5%
w/w
iv) Camphor 7.0%
w/w
Borden Company (Private)
Limited, Singapore
SP Setia Sdn Bhd 05 September 2018 till 04
September 2023
GSL
2029 BRU18072379P Eye Glo Plus Eye Drops i) Boric Acid 1.3% w/v
ii) Borax 0.3% w/v
iii) Distilled Witch Hazel 5%
w/v
Duopharma (M) Sdn Bhd, Malaysia Bintang Ria Sdn Bhd 05 September 2018 till 04
September 2023
GSL
2030 BRU18072380NP Crotamiton Cream 10% w/w Crotamiton 10% w/w SM Pharmaceuticals Sdn Bhd,
Malaysia
G&H Trading Company 05 September 2018 till 04
September 2023
GSL
2031 BRU18072381P MabThera® Solution for
Subcutaneous Injection
1400mg
Rituximab 120mg/mL F. Hoffmann-LA Roche Ltd,
Switzerland
MediPharm Sdn Bhd 05 September 2018 till 04
September 2023
POM
2032 BRU18082382P Tolanz ODT Tablets 5mg Olanzapine 5mg Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 05 September 2018 till 04
September 2023
POM
2033 BRU18082383P Tolanz ODT Tablets 10mg Olanzapine 10mg Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 05 September 2018 till 04
September 2023
POM
2034 BRU18082384NP BETADINE Gargle and
Mouthwash
Povidone-Iodine 1% w/v PT Mahakam Beta Farma,
Indonesia
Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04
September 2023
GSL
BDMCA/RMP/0319 Page 163 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2035 BRU18082385P Midazolam-Hameln 5mg/ml
Injection, 1ml
Midazolam (as hydrochloride)
5mg/ml
Hameln Pharmaceuticals GmbH,
Germany
Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
POM
2036 BRU18082386P Optimol Eye Drops 0.5% Timolol Maleate 0.5% Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 05 September 2018 till 04
September 2023
POM
2037 BRU18082387P Niferin SR 30mg tablet Nifedipine 30mg China Chemical & Pharmaceutical
Co. Ltd., R.O.C., Taiwan
Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
POM
2038 BRU18082388P Pethidine hydrochloride
50mg/1ml
Pethidine hydrochloride 50mg/ml Pharmaniaga Lifescience Sdn Bhd,
Malaysia
G&H Trading Company 05 September 2018 till 04
September 2023
POM
2039 BRU18082389P Pethidine hydrochloride
100mg/2ml
Pethidine hydrochloride
100mg/2ml
Pharmaniaga Lifescience Sdn Bhd,
Malaysia
G&H Trading Company 05 September 2018 till 04
September 2023
POM
2040 BRU18082390P TAGRISSO 40MG FILM-
COATED TABLETS
Osimertinib 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04
September 2023
POM
2041 BRU18082391P TAGRISSO 80MG FILM-
COATED TABLETS
Osimertinib 80mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04
September 2023
POM
2042 BRU18082392P Adezio Tablet 10mg Cetirizine Hydrohloride 10mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd
Hongkiat Trading & Company 05 September 2018 till 04
September 2023
P
2043 BRU18082393P Enapril Tablet 20mg Enalapril Maleate 20mg Y.S.P. Industries (M) Sdn Bhd Asterix United (B) Sdn Bhd 05 September 2018 till 04
September 2023
POM
2044 BRU18082394P XALKORI 200MG HARD
CAPSULES
Crizotinib 200mg Pfizer Manufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04
September 2023
POM
2045 BRU18082395P XALKORI 250MG HARD
CAPSULES
Crizotinib 250mg Pfizer Manufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04
September 2023
POM
2046 BRU18082396P Normaten Tablet 100mg Atenolol 100mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd
Hongkiat Trading & Company 05 September 2018 till 04
September 2023
POM
2047 BRU18082397P Brilinta 60mg Film-coated
Tablet
Ticagrelor 60mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04
September 2023
POM
2048 BRU18082398P Atswift 10 Film Coated Tablets Atorvastatin Calcium Trihydrate
equivalent to Atorvastatin 10mg
Ind-Swift Limited, India Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
POM
2049 BRU18082399P Atswift 20 Film Coated Tablets Atorvastatin Calcium Trihydrate
equivalent to Atorvastatin 20mg
Ind-Swift Limited, India Medicorp Sdn Bhd 05 September 2018 till 04
September 2023
POM
2050 BRU18082400P Normaten Tablet 50mg Atenolol 50mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd
Hongkiat Trading & Company 05 September 2018 till 04
September 2023
POM
2051 BRU18082401P Adroten Tablet 5mg Bisoprolol Fumarate 5mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd
Hongkiat Trading & Company 05 September 2018 till 04
September 2023
POM
BDMCA/RMP/0319 Page 164 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2052 BRU18092402P Mapenem (1G Injection) Meropenem trihydrate and sodium
carbonate 1.28g (equivalent to
Meropenem 1g)
Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn. Bhd 11 December 2018 till 10
December 2023
POM
2053 BRU18092403P (With
condition the porcine
information is stated
on the label)
Zostavax (Refrigerator Stable
Formulation) Injection
Live attenuated Oka/Merck
Varicella-Zoster Virus
Drug product
Merck Sharp & Dohme, USA
Diluent
Vetter Pharma-Fertigung GmbH &
Co. KG., Germany.
Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2054 BRU18092404P Apo-Fluvoxamine 50mg tablet Fluvoxamine maleate 50mg Apotex Inc. Canada, Canada Medicorp Sdn. Bhd 11 December 2018 till 10
December 2023
POM
2055 BRU18092405P Ultiva Injection 5mg Each single use vial contains 5mg
remifentanil (as hydrochloride).
GlaxoSmithKline Manufacturing,
S.P.A., Italy.
Zuellig Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2056 BRU18092406P Ultravist 300 Injection
300mg/Ml
1ml contains 623mg iopromide
(equivalent to 300mg iodine)
Bayer Pharma AG, Germany Zuellig Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2057 BRU18092407P Ultravist 370 Injection
370mg/Ml
1ml contains 769mg iopromide
(equivalent to 370mg iodine)
Bayer Pharma AG, Germany Zuellig Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2058 BRU18092408P Halaven 0.5mg/ml Solution
for Injection
Eribulin mesilate Biogen U.S. Corporation, USA. Medipharm Sdn Bhd 11 December 2018 till 10
December 2023
POM
2059 BRU18092409P Sivkort® Sterile Suspension for
injection 40mg/1ml
Triamcinolone acetonide 40mg /
1ml
Siu Guan Chem. Ind. Co. Ltd.,
Taiwan
K-Seri Pharma Sdn. Bhd. 11 December 2018 till 10
December 2023
POM
2060 BRU18092410P Dotarem 0.5 mmol/mL,
Solution for Injection
Per 100 mL of solution:
Gadoteric acid ……27.932 g
Corresponding to:
DOTA ……………20.246 g
Gadolinium oxide...9.062g
Contrast agent concentration:
0.5mmol/mL
Guerbet, France Manning Jaya Trading (B) Sdn
Bhd
11 December 2018 till 10
December 2023
POM
2061 BRU18092411P Polytet Eye Ointment Each gram contains:
Polymyxin B sulphate 6900 unit eq
to Polymyxin B 6000 units
Oxytetracycline hydrochloride
5.94mg eq to Oxytetracycline 5mg
SM Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 11 December 2018 till 10
December 2023
POM
BDMCA/RMP/0319 Page 165 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2062 BRU18092412P Latanoprost eye drops
solution 0.005%w/v
Latanoprost 0.05mg/ml FDC Limited, India K-Seri Pharma Sdn. Bhd. 11 December 2018 till 10
December 2023
POM
2063 BRU18092413NP Eye Glo Relief Eye Drops
0.25% w/v
Zinc Sulphate 0.25% w/v Duopharma (M) Sdn Bhd,
Malaysia
Bintang Ria Sdn Bhd 11 December 2018 till 10
December 2023
GSL
2064 BRU18092414NP Aqueous Cream Cetomacrogol 1000 2.75%w/w
White Soft Paraffin 17.85%w/w
Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 11 December 2018 till 10
December 2023
GSL
2065 BRU18092415P Axcel Cefuroxime-125 for Oral
Suspension (125mg/5ml)
Each 5ml contains:
Cefuroxime Axetil equivalent to
Cefuroxime 125mg
Kotra Pharma (M) Sdn. Bhd.,
NMalaysia
Medicorp Sdn Bhd 11 December 2018 till 10
December 2023
POM
2066 BRU18092416P
(Applicant to be
informed to remove
label "to be dispensed
on physician's
prescription")
Horf Lozenges Chlorhexidine Hydrochloride
5mg; Benzocaine 2mg
Y.S.P Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 11 December 2018 till 10
December 2023
P
2067 BRU18092417NP Salap Putih Tiger Balm Dementholised Mint Oil 16.0%
w/w; Cajuput Oil 13.0% w/w;
Camphor 11.0% w/w; Levomenthol
(Menthol) BP 8.0% w/w; Clove Oil
1.5% w/w
Haw Par Healthcare Ltd, Singapore Hamitan Marketing 11 December 2018 till 10
December 2023
GSL
2068 BRU18092418P Prolia Solution for Injection
60mg/mL (Prefilled Syringe)
Denosumab 60mg/mL Amgen Manufacturing Limited,
United States
MediPharm Sdn Bhd 11 December 2018 till 10
December 2023
POM
2069 BRU18102419PS1 &
BRU18102419PS2
Zient® 10mg Tablet Ezetimibe 10mg 1. MSD Internaitonal GmbH
(Singapore Branch), Singapore
2. MSD International GmbH
(Puerto Rico Branch) LLC, Puerto
Rico
Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2070 BRU18102420P Simulect Lyophilisate for
Injection 20mg per vial
Basiliximab 20mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2071 BRU18102421NP Calcium Lactate Tablet 300mg Calcium Lactate 300mg Sunward Pharmaceutical Sdn Bhd,
Malaysia
G&H Trading Company 11 December 2018 till 10
December 2023
GSL
2072 BRU18102422P Sulpin F.C. Tablets 200mg Sulpiride 200mg Taiwan Biotech Co. Ltd., Taiwan,
Republic of China
K-Seri Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2073 BRU18102423P Quetiapine Fumarate Tablets
25mg
Quetiapine 25mg (as Quetiapine
Fumarate 28.78mg)
Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
BDMCA/RMP/0319 Page 166 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2074 BRU18102424P Quetiapine Fumarate Tablets
200mg
Quetiapine 200mg (as Quetiapine
Fumarate 230.26mg)
Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2075 BRU18102425P Quetiapine Fumarate Tablets
100mg
Quetiapine 100mg (as Quetiapine
Fumarate 115.13mg)
Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2076 BRU18102426NP Volulyte 6% Solution for
Infusion
Active ingredient (per 1000 ml)
Poly (O-2-hydroxylethyl) starch
60.0 g
Sodium acetate trihydrate 4.63 g
Sodium chloride 6.02 g
Potassium chloride 0.30 g
Magnesium chloride hexahydrate
0.30 g
Fresenius Kabi Deutchland GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2077 BRU18102427P Hydrogen Peroxide Solution
6% w/v
Hydrogen Peroxide 6% w/v Royce Pharma Manufacturing Sdn
Bhd, Malaysia
SWL Biomed Sales & Services 11 December 2018 till 10
December 2023
GSL
2078 BRU18102428P Axcel Prednisolone-5mg EC
Tablets
Prednisolone 5mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 11 December 2018 till 10
December 2023
POM
2079 BRU18102429P Praluent 75mg Solution for
Injection in Pre-filled Pen
Alirocumab 75mg/ml Sanofi-Aventis Deutschland
GmbH, Germany
Medipharm Sdn Bhd 11 December 2018 till 10
December 2023
POM
2080 BRU18102430P Praluent 150mg Solution for
Injection in Pre-filled Pen
Alirocumab 150mg/ml Sanofi-Aventis Deutschland
GmbH, Germany
Medipharm Sdn Bhd 11 December 2018 till 10
December 2023
POM
2081 BRU18102431P Praluent 75mg Solution for
Injection in Pre-filled Syringe
Alirocumab 75mg/ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 11 December 2018 till 10
December 2023
POM
2082 BRU18102432P Praluent 150mg Solution for
Injection in Pre-filled Syringe
Alirocumab 150mg/ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 11 December 2018 till 10
December 2023
POM
2083 BRU18102433P Udoxan Injection (1 ml
amp)
Oxytocin (synthetic) 10 I.U. /ml Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2084 BRU18102434P Lignopad®medicated plaster
5%w/w
Lidocaine 5% w/w Teikoku Seiyaku Co Ltd, Japan K-Seri Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2085 BRU18102435P CEFTREX INJECTION 1G IV
CEFTRIAXONE
Ceftriaxone sodium equivalent to
Ceftriaxone 1G
Biolab Co Ltd, Thailand Hongkiat Trading & Company 11 December 2018 till 10
December 2023
POM
BDMCA/RMP/0319 Page 167 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2086 BRU18102436P Doxymycin-100 Capsules Doxycycline Hyclate BP equivalent
to Doxycycline 100mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 11 December 2018 till 10
December 2023
POM
2087 BRU18102437NP Optrex Multi Action Eye Wash Hamamelis Water (Witch Hazel)
13.0% v/v
Reckitt Beckinser Healthcare
International Ltd, UK
Syarikat Aliaa Sdn Bhd 11 December 2018 till 10
December 2023
GSL
2088 BRU18102438NP Optrex Rehydrating Eye Drops Sodium Hyaluronate 0.165%w/w Reckitt Beckinser Healthcare
International Ltd, UK
Syarikat Aliaa Sdn Bhd 11 December 2018 till 10
December 2023
GSL
2089 BRU18102439P Candesartan Sandoz tablet
8mg
Candesartan cilexetil 8mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2090 BRU18102440P Keytruda 25mg/mL Pembrolizumab 25mg/mL MSD Ireland (Carlow), Ireland Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2091 BRU18112441NP African Sea Coconut Brand
Cough MIxture
Tolutanus Syrup BP 4.48% v/v;
Tincture of Ipecacuanha BP 1953
2.24% v/v; Solution for Making
Squill Elixir BP 1980 2.24% v/v;
Liquorice Liquid Extract BP 2.24%
v/v
Luen Fook Medicine (M) Sdn Bhd,
Malaysia
Yuh Hua Trading Company 11 December 2018 till 10
December 2023
GSL
2092 BRU18112442P FRESOFOL 2% MCT/LCT
EMULSION FOR INJECTION OR
INFUSION
Propofol 20mg/ml Fresenius Kabi Austria GMBH
(Plant Graz), Austria
Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2093 BRU18112443P FRESOFOL 1% MCT/LCT
EMULSION FOR INJECTION OR
INFUSION
Propofol 10mg/ml Fresenius Kabi Austria GMBH
(Plant Graz), Austria
Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2094 BRU18112444NP SURGICAL SPIRIT Methylated spirit 98.8% v/v Sanchuan Medical Sdn BHd,
Malaysia
SWL Biomed Sales & Services 11 December 2018 till 10
December 2023
GSL
2095 BRU18112445P ANDROZ 100 TABLET 100mg Sildenafil (as Sildenafil
citrate 140.485mg)
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2096 BRU18112446P ANDROZ 50 TABLET 50mg Sildenafil (as Sildenafil
citrate 70.243mg)
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2097 BRU18112447P VERAPIME POWDER FOR
SOLUTION FOR INJECTION
1G/VIAL
Cefepime Hydrochloride
Monohydrate equivalent to
Cefepime 1g
DEMO S.A. Pharmaceutical
Industry, Greece
Medicorp Sdn Bhd 11 December 2018 till 10
December 2023
POM
BDMCA/RMP/0319 Page 168 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2098 BRU18112448PS1;
BRU18112448PS2
REBIF SOLUTION FOR
INJECTION IN PRE-FILLED PEN
22MCG/0.5ML
Each Rebif 22 micrograms solution
for injection in pre-filled pen
contains 22 micrograms (6MIU*) of
interferon beta-1a** in 0.5ml
solution
* Million International Units,
measured by cytopathic effect
(CPE) bioassay against the in-house
IFN beta-1a standard which is
calibrated against the current
international NIH standard (GB-23-
902-531).
** produced in Chinese hamster
ovary Cells (CHO-K1) by
recombinant DNA technology
1) Merck Serono S.p.A., Italy
2) Merck Serono S.A., Switzerland
G&H Trading Company 11 December 2018 till 10
December 2023
POM
2099 BRU18112449PS1;
BRU18112449PS2
REBIF SOLUTION FOR
INJECTION IN PRE-FILLED PEN
44MCG/0.5ML
Each Rebif 44 micrograms solution
for injection in pre-filled pen
contains 44 micrograms (12MIU*)
of interferon beta-1a** in 0.5ml
solution
* Million International Units,
measured by cytopathic effect
(CPE) bioassay against the in-house
IFN beta-1a standard which is
calibrated against the current
international NIH standard (GB-23-
902-531).
** produced in Chinese hamster
ovary Cells (CHO-K1) by
recombinant DNA technology
1) Merck Serono S.p.A., Italy
2) Merck Serono S.A., Switzerland
G&H Trading Company 11 December 2018 till 10
December 2023
POM
BDMCA/RMP/0319 Page 169 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2100 BRU18112450PS1;
BRU18112450PS2
REBIF SOLUTION FOR
INJECTION IN PRE-FILLED
CARTRIDGE 22MCG/0.5ML
Each pre-filled cartridge contains
66 micrograms (18 MIU*) of
interferon beta-1 a** in 1.5mL
solution, corresponding to 44
micrograms/rnl.
* Million International Units,
measured by cytopathic effect
(CPE) bioassay against the in-house
IFN beta-1a standard which is
calibrated against the current
international NIH standard (GB-23-
902-531).
** produced in Chinese hamster
ovary Cells (CHO-K1) by
recombinant DNA technology.
1) Merck Serono S.p.A., Italy
2) Merck Serono S.A., Switzerland
G&H Trading Company 11 December 2018 till 10
December 2023
POM
2101 BRU18112451PS1;
BRU18112451PS2
REBIF SOLUTION FOR
INJECTION IN PRE-FILLED
CARTRIDGE 44 MCG/0.5ML
Each pre-filled cartridge contains
132 micrograms (36 MIU*) of
interferon beta-1 a** in 1.5mL
solution, corresponding to 88
micrograms/rnl.
* Million International Units,
measured by cytopathic effect
(CPE) bioassay against the in-house
IFN beta-1a standard which is
calibrated against the current
international NIH standard (GB-23-
902-531).
** produced in Chinese hamster
ovary Cells (CHO-K1) by
recombinant DNA technology.
1) Merck Serono S.p.A., Italy
2) Merck Serono S.A., Switzerland
G&H Trading Company 11 December 2018 till 10
December 2023
POM
2102 BRU18112452P Nelin 150mg/1.5mL Injection Netilmicin Sulfate USP Eq. to
Netilmicin 150mg/1.5mL
Biolab Company Ltd, Thailand K-Seri Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
BDMCA/RMP/0319 Page 170 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2103 BRU18112453P Midazolam-Hameln 5mg/ml
Injection, 3ml
Midazolam (as hydrochloride)
15mg/3ml
Hameln Pharmaceuticals GmbH,
Germany
Medicorp Sdn Bhd 11 December 2018 till 10
December 2023
POM
2104 BRU18112454P APO-ATENIDONE TABLETS
100/25MG
Atenolol 100mg and
Chlorthalidone 25mg
Apotex Inc, Canada Medicorp Sdn Bhd 11 December 2018 till 10
December 2023
POM
2105 BRU18112455P Torio Tablet Simvastatin 10mg Unison Laboratories Co. Ltd.,
Thailand
K-Seri Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2106 BRU18112456P Arvastatil 10mg Film Coated
Tablets
Atorvastatin calcium Trihydrate eq.
to Atorvastatin 10mg
One-Pharma Industrial
Pharmaceutical Company S.A.,
Greece
Medicorp Sdn Bhd 11 December 2018 till 10
December 2023
POM
2107 BRU18112457P Arvastatil 20mg Film Coated
Tablets
Atorvastatin calcium Trihydrate eq.
to Atorvastatin 20mg
One-Pharma Industrial
Pharmaceutical Company S.A.,
Greece
Medicorp Sdn Bhd 11 December 2018 till 10
December 2023
POM
2108 BRU18112458P Arvastatil 40mg Film Coated
Tablets
Atorvastatin calcium Trihydrate eq.
to Atorvastatin 40mg
One-Pharma Industrial
Pharmaceutical Company S.A.,
Greece
Medicorp Sdn Bhd 11 December 2018 till 10
December 2023
POM
2109 BRU18112459P Ificipro 250mg Tablets Ciprofloxacin Hydrochloride USP
eq. to Ciprofloxacin 250mg
Unique Pharmaceutical
Laboratories (A Division of JB
Chemicals & Pharmaceuticals
Limited), India
K-Seri Pharma Sdn Bhd 11 December 2018 till 10
December 2023
POM
2110 BRU18112460P Humira 40mg/0.4ml Solution
for Injection
Adalimumab 40mg/0.4ml Vetter Pharma-Fertigung,
Germany
Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2111 BRU18112461P IMACH INJECTION 1ML Chlorpheniramine maleate
10mg/1ml
SM Pharmaceuticals Sdn Bhd,
Malaysia
G&H Trading Company 11 December 2018 till 10
December 2023
POM
2112 BRU18112462NP Silverderm cream Silver Sulfadiazine 1% w/w T.O. Chemicals (1979) Ltd,
Thailand
Medicorp Sdn Bhd 11 December 2018 till 10
December 2023
P
2113 BRU18112463P Granisetron-AFT Solution for
Injection 1mg/ml
Granisetron hydrochloride
equivalent to Granisetron 1mg/ml
Qilu Pharmaceutical Co. Ltd., P.R.
China
Medipharm Sdn Bhd 11 December 2018 till 10
December 2023
POM
2114 BRU18112464P Lenvima 4mg Hard Capsule Lenvatinib 4mg (equivalent to
4.90mg levatinib mesilate)
Patheon Inc., Canada Medipharm Sdn Bhd 11 December 2018 till 10
December 2023
POM
2115 BRU18112465P Lenvima 10mg Hard Capsule Lenvatinib 10mg (equivalent to
12.25mg levatinib mesilate
Patheon Inc., Canada Medipharm Sdn Bhd 11 December 2018 till 10
December 2023
POM
2116 BRU18112466P KISQALI 200MG FILM-COATED
TABLET
Ribociclib succinate equivalent to
200mg ribociclib
Novartis Singapore
Pharmaceutical Manufacturing Pte
Ltd., Singapore
Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10
December 2023
POM
2117 BRU18112467P Zylovaa Tablet 50mg Losartan Potassium 50mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 11 December 2018 till 10
December 2023
POM
BDMCA/RMP/0319 Page 171 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2118 BRU18122468P CLOXABIOTIC INJECTION
500MG
Cloxacillin sodium BP equivalent to
cloxacillin 500mg
Karnataka Antibiotics &
Pharmaceuticals Limited (A. Govt
of India Enterprise), India
K-Seri Pharma Sdn. Bhd 04 March 2019 till 03 March
2024
POM
2119 BRU18122469P Losartan Potassium Tablet
50mg
Losartan Potassium 50mg Jubilant Generics Limited, INDIA. Asterix United (B) Sdn Bhd. 04 March 2019 till 03 March
2024
POM
2120 BRU18122470P Losartan Potassium Tablet
100mg
Losartan Potassium 100mg Jubilant Generics Limited, INDIA. Asterix United (B) Sdn Bhd. 04 March 2019 till 03 March
2024
POM
2121 BRU18122471P Injecsol LIG2 (Lignocaine
Hydrochloride Injection 2%
w/v)
Lignocaine Hydrochloride 20mg
/mL
Ain Medicare Sdn. Bhd, Malaysia. Syarikat Pakatan Indah 04 March 2019 till 03 March
2024
POM
2122 BRU18122472NP Injecsol S20 (Sodium Chloride
20% w/v Injection BP)
Each 10ml contains Sodium
chloride 2g (Na+ 34.2mmol, CL-
34.2mmol)
Ain Medicare Sdn. Bhd., Malaysia. Syarikat Pakatan Indah 04 March 2019 till 03 March
2024
POM
2123 BRU18122473P Dyna Ferrous Fumarate Tablet Ferrous Fumarate 200mg Dynapharm (M) Sdn Bhd (65683-
V), Pulau Pinang, Malaysia
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
GSL
2124 BRU18122474P OXYNORM 5MG CAPSULES Each capsule contains:
4.5mg oxycodone as 5mg
oxycodone hydrochloride.
Bard Pharmaceuticals Limited,
United Kingdom.
Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
2125 BRU18122475P OXYNORM 10MG CAPSULES Each capsule contains:
9mg oxycodone as 10mg
oxycodone hydrochloride.
Bard Pharmaceuticals Limited,
United Kingdom.
Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
2126 BRU18122476P OXYNORM 20MG CAPSULES Each capsule contains:
18mg oxycodone as 20mg
oxycodone hydrochloride.
Bard Pharmaceuticals Limited,
United Kingdom.
Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
2127 BRU18122477P Signifor LAR 20mg Powder
and Solvent for Suspension for
Injection
Pasireotide 20mg (as pamoate) Powder
Novartis Pharma AG, Switzerland
Sandoz GmbH, Austria
Solvent
Abbott Biologicals B.V., The
Netherlands
Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
BDMCA/RMP/0319 Page 172 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2128 BRU18122478P Signifor LAR 40mg Powder
and Solvent for Suspension for
Injection
Pasireotide 40mg (as pamoate) Powder
Novartis Pharma AG, Switzerland
Sandoz GmbH, Austria
Solvent
Abbott Biologicals B.V., The
Netherlands.
Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
2129 BRU18122479P Signifor LAR 60mg Powder
and Solvent for Suspension for
Injection
Pasireotide 60mg (as pamoate) Powder
Novartis Pharma AG, Switzerland
Sandoz GmbH, Austria
Solvent
Abbott Biologicals B.V., The
Netherlands.
Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
2130 BRU18122480PS1 &
BRU18122480PS2
MUCODIN TABLET 375MG Carbocysteine 375mg 1. Sunward Pharmaceutical Sdn
Bhd, Malaysia;
2. Sunward Pharmaceutical Pte
Ltd, Singapore,
Note: Both sites conducts their
batch releases and share the same
package insert and label artwork
G & H Trading Company 04 March 2019 till 03 March
2024
P
2131 BRU18122481P Kary Uni® Ophthalmic
Suspension (Pirenoxine
0.005%)
Pirenoxine 0.05mg/ mL Santen Pharmaceutical Co., Japan MediPharm Sdn Bhd 04 March 2019 till 03 March
2024
POM
BDMCA/RMP/0319 Page 173 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2132 BRU18122482NP Belcid Suspension Each 15ml contains:
Aluminum Hydroxide Gel USP eq.
to Aluminium Hydroxide 918mg
Magnesium Hydroxide USP
300mg
Simethicone USP 60mg
Biolab Company Ltd., Thailand. Hongkiat Trading & Company 04 March 2019 till 03 March
2024
GSL
2133 BRU18122483NP Eye Glo Moist Eye Drops Hydroxypropyl methylcellulose
0.3% w/v
Duopharma (M) Sdn Bhd,
Malaysia.
Bintang Ria Sdn Bhd 04 March 2019 till 03 March
2024
GSL
2134 BRU18122484NP Mifulin lotion Salicylic acid 12% Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 04 March 2019 till 03 March
2024
GSL
2135 BRU18122485P Ketazon shampoo Ketoconazole 2g/100ml Siam Bheasach Co Ltd, Thailand K-Seri Pharma Sdn. Bhd. 04 March 2019 till 03 March
2024
P
2136 BRU18122486P DURATOCIN® 100mcg/ml
Injection
Carbetocin 100mcg/ml Ferring GmbH, Germany
Repacker: Zuellig Pharma Specialty
Solutions Group Pte. Ltd.,
Singapore
Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
2137 BRU18122487NP Alucid Suspension Each 10ml contains:
Aluminium Hydroxide 800mg,
Magnesium Hydroxide 800mg,
Simethicone 60mg
Upha Pharmaceutical
Manufacturing (M) Sdn Bhd,
Malaysia
Bintang Ria Sdn Bhd 04 March 2019 till 03 March
2024
GSL
2138 BRU19012488P BENZAPEN 2.4MIU INJECTION Sterile Penicillin G Benzathine 1.8G
(2.4 MU)
Karnataka Antibiotics &
Pharmaceuticals Ltd., India
K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March
2024
POM
2139 BRU19012489NP VITBION FORTE TABLET Vitamin B1 HCl (Thiamine HCl)
100mg
Vitamin B6 HCL (Pyridoxine HCl)
200mg
Vitamin B12 HCL (Cyanocobalamin)
200mcg
Dynapharm (M) Sdn Bhd,
Malaysia.
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
GSL
2140 BRU19012490NP MENTHOLATUM DEEP
HEATING PLASTER
L-Menthol 4.26% Teh Seng Pharmaceutical Mfg. Co.,
Ltd., Taiwan, R.O.C
Hamitan Marketing 04 March 2019 till 03 March
2024
GSL
2141 BRU19012491P FENTANYL-HAMELN 50
MCG/ML INJECTION
Fentanyl citrate (0.157mg) eq. to
fentanyl 0.1mg/2ml
Hameln Pharmaceuticals GmbH,
Germany
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
POM
2142 BRU19012492P AXINOL TABLET 20MG Trimetazidine dihydrochloride
20mg
T.O Chemicals (1970) Co. Ltd.,
Thailand.
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
POM
BDMCA/RMP/0319 Page 174 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2143 BRU19012493P HCQS
(HYDROXYCHLOROQUINE
TABLETS BP 200MG)
Hydroxychloroquine Sulfate BP
200mg
Ipca Laboratories Limited, India. K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March
2024
POM
2144 BRU19012494P VAXCEL CEFEPIME 1G
INJECTION
Cefepime Hydrochloride buffered
with L-Arginine equivalent to
Cefepime 1g
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
POM
2145 BRU19012495NP POVIDONE IODINE, THREE
LEGS BRAND
Povidone Iodine 10% w/v Syarikat Wen Ken Drug Sdn Bhd,
Malaysia
Syarikat Rajamas Bersama 04 March 2019 till 03 March
2024
GSL
2146 BRU19012496P ALTRATM TABLET 10MG Montelukast 10mg (as
montelukast sodium 10.66mg)
Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Co. 04 March 2019 till 03 March
2024
POM
2147 BRU19012497P AXCEL DIPHENHYDRAMINE
PAEDIATRIC SYRUP
Diphenhydramine hydrochloride
7mg / 5ml
Ammonium chloride 67.5mg / 5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
POM
2148 BRU19012498NP VISIPAQUE 320 MG I/ML,
SOLUTION FOR INJECTION
Iodixanol 652 mg/ml eq to 320 mg
I/ml
GE Healthcare (Shanghai) Co., Ltd,
China
Medipharm Sdn Bhd 04 March 2019 till 03 March
2024
POM
2149 BRU19012499PS1 &
BRU19012499PS2
ALBUNORM 20%, 200G/L,
SOLUTION FOR INFUSION
200g/l of total protein of which at
least 96% is human albumin
i) Octapharma Pharmazeutika
Produktionsges.m.b.H, Austria
ii) Octapharma
Produktionsgesellschaft
Deutschland mbH, Germany
G&H Trading Company 04 March 2019 till 03 March
2024
POM
2150 BRU19012500PS1 &
BRU19012500PS2
ALBUNORM 5%, 50G/L,
SOLUTION FOR INFUSION
50g/l of total protein of which at
least 96% is human albumin
i) Octapharma Pharmazeutika
Produktionsges.m.b.H, Austria
ii) Octapharma
Produktionsgesellschaft
Deutschland mbH, Germany
G&H Trading Company 04 March 2019 till 03 March
2024
POM
2151 BRU19012501PS1 &
BRU19012501PS2
ALBUNORM 25%, 250G/L,
SOLUTION FOR INFUSION
250g/l of total protein of which at
least 96% is human albumin
i) Octapharma Pharmazeutika
Produktionsges.m.b.H, Austria
ii) Octapharma S.A.S., Lingolsheim,
France.
G&H Trading Company 04 March 2019 till 03 March
2024
POM
BDMCA/RMP/0319 Page 175 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2152 BRU19012502P VAXIGRIP TETRA SUSPENSION
FOR INJECTION IN PREFILLED
SYRINGE
A/Michigan/45/2015
(H1N1)pdm09 – like strain
(A/Michigan/45/2015, NYMC X-
275)….....
15 mcg HA**
A/Switzerland/8060/2017 (H3N2)
– like train (A/Brisbane/1/2018,
NYMC X-311)........
15 mcg HA**
B/Colorado/06/2017 like strain
(B/Maryland/15/216, NYMC BX-
69A)…………
15 mcg HA**
B/Phuket/3073/2013 – like strain
(B/Phuket/3073/2013, wild
type)………
15 mcg HA**
For one 0.5ml dose
*propagated in fertilised hen’s
eggs from healthy chicken flocks
**haemagglutinin
Sanofi Pasteur, Val De Reuil,
France
Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
2153 BRU19012503NP REGIOCIT SOLUTION FOR
HAEMOFILTRATION
Sodium chloride 5.03 g/L
Sodium citrate 5.29 g/L
Bieffe Medital S.p.A., Italy Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
POM
2154 BRU19012504P PYRONIUM INJECTION
200MCG/ML
Glycopyrrolate 200mcg/ml SM Pharmaceuticals Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
POM
2155 BRU19012505P HERCEPTIN SOLUTION FOR
INJECTION 600MG/5ML
Trastuzumab 600mg/5ml F.Hoffmann-La Roche Ltd.,
Kaiseraugst, Switzerland
Medipharm Sdn Bhd 04 March 2019 till 03 March
2024
POM
2156 BRU19012506P EZETIMIBE SANDOZ TABLET
10MG
Ezetimibe 10mg Lek Pharmaceuticals, Ljubljana,
Slovenia
Zuellig Pharma (B) Sdn. Bhd 04 March 2019 till 03 March
2024
POM
BDMCA/RMP/0319 Page 176 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2157 BRU19022507P APO-FLUCONAZOLE 100MG
TABLETS
FLUCONAZOLE 100MG Apotex Inc., Canada Medipharm Sdn Bhd 04 March 2019 till 03 March
2024
POM
2158 BRU19022508NP NUTRILITE IRON FOLIC TABLET IRON 10MG
FOLATE (FOLIC ACID) 0.133MG
Access Business Group LLC, USA Amway (B) Sdn Bhd 04 March 2019 till 03 March
2024
GSL
2159 BRU19022509P CEFATUM INJECTION 1G CEFTAZIDIME 1GM Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 04 March 2019 till 03 March
2024
POM
2160 BRU19022510NP Folic Acid Tablets 5mg FOLIC ACID 5MG HOVID Bhd., Malaysia G&H Trading Company 04 March 2019 till 03 March
2024
GSL
2161 BRU19022511P Clopine 100MG Tablet Clozapine 100mg Douglas Manufacturing Ltd., New
Zealand
K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March
2024
POM
2162 BRU19022512P Vaxcel Omeprazole 40mg
Injection
Omeprazole Sodium equivalent to
Omeprazole 40mgKotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
POM
2163 BRU19022513NP Medon 500 capsule Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 04 March 2019 till 03 March
2024
GSL
2164 BRU19022514P Bufencon Injection Betamethasone (as dipropionate) 5mg
& Betamethasone (as phosphate
disodium) 2mg
Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan, Republic of China
Asterix (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
2165 BRU19022515NP PARACETAMOL-AFT
SOLUTION FOR INFUSION
10MG/ML
Paracetamol 10mg/ml S.M. Farmaceutici SRL, Italy MediPharm Sdn Bhd 04 March 2019 till 03 March
2024
POM
2166 BRU19022516P Domi Injection 15mg (3ml
Amp)
Midazolam HCl equivalent to
Midazolam 15mg/3mlDuopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March
2024
POM
2167 BRU19022517P Baraclude® 0.5mg Tablets Entecavir 0.5mg Bristol-Myers Squibb Company,
USA
Medipharm Sdn Bhd 04 March 2019 till 03 March
2024
POM
2168 BRU19022518NP Tricera Cleanser 1.6% w/w Pine Tar 1.6% HOE Pharmaceuticals Sdn Bhd,
Malaysia
G&H Trading Company 04 March 2019 till 03 March
2024
GSL
2169 BRU19022519P Chloroquine Tablets 250mg Chloroquine Phosphate BP 250mg
equivalent to Chloroquine Base
150mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 04 March 2019 till 03 March
2024
POM
2170 BRU19022520P KENO ORAL PASTE Triamcinolone acetonide 1 mg/g T.O. CHEMICALS (1979) LTD.,
Thailand
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
POM
2171 BRU19022521P ATRACURIUM-HAMELN
10MG/ML INJECTION, 2.5ML
Atracurium besilate 25mg in 2.5ml
(10mg/ml)
Hameln Pharmaceuticals GmbH,
Germany
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
POM
2172 BRU19022522NP Kidz PCM 250 Suspension
(Strawberry)
Paracetamol 250mg/5ml Winwa Medical Sdn Bhd, Pulau
Pinang, Malaysia
Yuh Hua Trading Company 04 March 2019 till 03 March
2024
GSL
2173 BRU19022523NP Povil Antacid Tablet Dried Aluminium Hydroxide 250 mg,
Magnesium Hydroxide 250 mg,
Simethicone 50 mg
Winwa Medical Sdn Bhd, Pulau
Pinang, Malaysia
Medicorp Sdn Bhd 04 March 2019 till 03 March
2024
GSL
BDMCA/RMP/0319 Page 177 of 178
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
2174 BRU19022524P Inlyta® 1mg Film-Coated
Tablet
Axitinib 1mg Pfizer manufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn. Bhd 04 March 2019 till 03 March
2024
POM
2175 BRU19022525P Inlyta® 5mg Film-Coated
Tablet
Axitinib 5mg Pfizer manufacturing Deutschland
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
2176 BRU19022526P Taflotan Ophthalmic Solution
0.0015%
Tafluprost 0.00015% Santen Pharmaceutical Co., Ltd.,
Shiga Plant, Japan
MediPharm Sdn Bhd 04 March 2019 till 03 March
2024
POM
2177 BRU19022527NP Paracil suspension 250mg/5ml Paracetamol 250mg/5ml SM Pharmaceuticals Sdn Bhd,
Malaysia
G& H Trading Company 04 March 2019 till 03 March
2024
GSL
2178 BRU19022528P DTI for Injection 200mg Dacarbazine 200mg Korea United Pharm, Inc., Republic
of Korea
Kingsley Medical Supplies
Sdn Bhd
04 March 2019 till 03 March
2024
POM
2179 BRU19022529P Sildegra 100mgTablets Sildenafil Citrate 140.4mg
equivalent to Sildenafil 100mg
Sandoz Private Limited, India Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March
2024
POM
BDMCA/RMP/0319 Page 178 of 178
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