BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016) 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 BRU08010009P Meronem Injection 1g Meropenem (as trihydrate) 1g AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM 9 BRU08020010P Meronem Injection 500mg Meropenem (as trihydrate) 500mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM 10 BRU08020011P Bactroban Cream Mupirocin 2% SmithKline Beecham, Philippines Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM 11 BRU08020012P Pharmaniaga Cephalexin Capsule 500mg Cephalexin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 12 BRU08020013P Pharmaniaga Metronidazole Tablet 200mg Metronidazole 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 13 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05 October 2015 (PL extended to 26 March 2017) POM 14 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05 October 2015 (PL extended to 26 March 2017) POM 15 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05 October 2015 (PL extended to 26 March 2017) POM BDMCA/RMP/1116 Page 1 of 117
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
38 BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
39 BRU08040049P Diflucan IV Infusion 2mg/ml
(50ml)
Fluconazole 2mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
43 BRU08050053P Pharmaniaga Aciclovir Tablet
400mg
Aciclovir 400mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
44 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
45 BRU08050058P Ketozotan Tablet 200mg Ketoconazole 200mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
46 BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
BDMCA/RMP/1116 Page 3 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
47 BRU08050061P Unocef Injection 1000mg (Vial) Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
49 BRU08050064P Solulexin Capsule 500mg Cephalexin (as Monohydrate) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
50 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
51 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
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
53 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
54 BRU08050069P Plaquenil Tablet Hydroxychloroquine Sulphate 200mg Sanofi-Aventis, S.A., Riells l Viabrea, Spain Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
55 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
56 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/v Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
64 BRU08060080P Beta Eye/ Ear Drops Betamethasone Sodium Phosphate 0.1% Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
69 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
70 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
71 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
72 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
73 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
74 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
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
76 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
BDMCA/RMP/1116 Page 5 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
77 BRU08070096P Betamox Capsule 250mg Amoxicillin Trihydrate equivalent to
Amoxicillin 250mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
78 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
79 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
80 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
81 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
82 BRU08070102P Fortum® Injection 500mg Ceftazidime (as Pentahydrate) 500mg GlaxoSmithKline Manufacturing SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
83 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
84 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
85 BRU08080106P Candazole Cream Clotrimazole 1.0% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
GSL
86 BRU08080107P Gentamicin Cream Gentamicin (as Sulphate) 0.1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
101 BRU08090122P Hepsera Tablet 10mg Adefovir dipivoxil 10mg GlaxosmithKline (Tianjin) Co.Ltd, China Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
102 BRU08090124P Ciprobay® 200 Infusion Solution Ciprofloxacin (as lactate) 200mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
103 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
104 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
105 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
106 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
107 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
108 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
Sanofi Pasteur France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
127 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
128 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
129 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
130 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
131 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
132 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
133 BRU08110157P Soden Tablet 275mg Naproxen Sodium BP 275mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
134 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)
135 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
BDMCA/RMP/1116 Page 8 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
136 BRU08110160P Malarone Tablet Atovaquone 250mg, Proguanil HCl 100mg GlaxoSmithKline Inc Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
137 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
138 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
139 BRU08110164P Dhaperazine Tablet 5mg Prochlorperazine (as maleate) 5mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
140 BRU08110165P Betasone Cream 0.1%w/w Betamethasone (as 17-valerate) 0.1%w/w Drug Houses of Australia Pte Ltd G & H Trading Company 06 October 2015 till 05
October 2020
POM
141 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
142 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
143 BRU08120168P Axcel Cephalexin 125mg
Suspension
Cephalexin (as Monohydrate) 125mg Kotra Pharma (M) Sdn Bhd Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
145 BRU08120172P Betamox Tablet 125 Amoxicillin (as trihydrate) 125mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
146 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
147 BRU08120174P Dhacopan Syrup 5mg/5ml Hyoscine (as butylbromide) BP 5mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
148 BRU08120175P Phenexpect Syrup Per 5ml - Diphenhydramine (as HCl)
12.5mg, Ammonium Chloride 135mg
Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
149 BRU08120176P Dhabesol Cream 0.05% Clobetasol (as propionate) 0.05% w/v Drug Houses of Australia Pte Ltd,
159 BRU09010186P Plavix Tablet 75mg Clopidogrel (as Hydrogen Sulphate) 75mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
160 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
161 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
162 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
163 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
164 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
165 BRU09010192P Dhacopan Tablet Hyoscine (as butylbromide) BP 10mg Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
166 BRU09010194P Pulmicort turbuhaler
100mcg/dose
Budenoside 100mcg AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
167 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
168 BRU09020196P Zovirax Cream 5% Aciclovir 5%w/w Glaxo Wellcome Opertions, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
173 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
HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
176 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
177 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
178 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
179 BRU09020212P Glucobay 50 Tablet Acarbose 50mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
180 BRU09030213P 3TC Tablet 150mg Lamivudine 150mg Glaxo Wellcome Operaions, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
181 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
182 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
183 BRU09030216P Cordarone Injection 150mg/3ml Amiodarone 150mg/3ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
184 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
185 BRU09030218P0.5gS &
BRU09030218P0.5gA
Tetavax Suspension for Injection
(Single dose 0.5ml)
Purified Tetanus Toxoid Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
186 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/1116 Page 11 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
187 BRU09030220P Vaxigrip Influenza Vaccine Strain composition for Influenza Vaccine
complies with the WHO recommendations
and EU Recommendations for the
Northern Hemisphere 2015/2016 year
influenza season.
Active substance(s):
Split influenza virus, inactivated containing
antigens equivalent to the following strains
per one 0.5ml dose:
• A/California/7/2009 (H1N1)pdm09-like
strain (A/California/7/2009, NYMC X-179A)
• A/Switzerland/9715293/2013 (H3N2)-like
strain (A/South Australia/55/2014, IVR-
175)
• B/Phuket/3073/2013
Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
188 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
189 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
190 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
194 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
195 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
196 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
197 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
198 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
199 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 Insutrial d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
200 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
201 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
209 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
210 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
211 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
212 BRU09040245P Bisacodyl Suppositroies Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
P
213 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
214 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden G & H Trading Company 06 October 2015 till 05
October 2020
POM
215 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)
216 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
217 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
218 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
219 BRU09050252P Glucobay Tablet 100mg Acarbose 100mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
223 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
224 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
BDMCA/RMP/1116 Page 14 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
226 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
227 BRU09060260P Tetavax Suspension for Injection Tetanus toxoid 40i.u/0.5ml dose Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
228 BRU09060262P Betamox Tablet 250mg Amoxicillin (as trihydrate) 250mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
229 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Pharma SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
230 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
231 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
232 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
233 BRU09060267NP Uphamol 250 Syrup Paracetamol 250mg/5ml Upha Pharmaceutical Mfg (M) Sdn Bhd Hongkiat Trading & Company 06 October 2010 till 05
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
273 BRU09090312P Euvax B Vaccine, Recombinant
(100µg/5ml)
Purified Hepatitis B surface antigen
(HBsAg) 100µg/5ml
LG Life Science Ltd, Korea Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
274 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
275 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
276 BRU09090315P Amaryl 2mg Tablet Glimepride 2mg Sanofi-aventis S.p.A, Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
277 BRU09090316P Lamisil® 250mg Tablet Terbinafine HCl 250mg Novartis Pharmaceuticals UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
278 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
279 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mg Novartis Urunleri, Istanbul Turkey Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
Novartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 17 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
289 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 Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
290 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
291 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
292 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical Sdn Bhd,
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
294 BRU09100336NP Sunquadin Lozenges Dequalinium Chloride Sunward Pharmaceutical Sdn Bhd,
Malaysia.
G & H Trading Company 06 October 2015 till 05
October 2020
POM
295 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
346 BRU10010401P VentolinTM Tablet 4mg Salbutamol 4mg (as Sulphate 4.8mg) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
347 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
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
350 BRU10020406P Combivent Unit Dose Vial 500mcg 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
351 BRU10020408P Guadex Linctus Per 5ml - Dextromethorphan
Hydrobromide 15mg; Guaifenesin 100mg
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
352 BRU10020409P Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
353 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
354 BRU10020411P Decondine Syrup Per 5ml - Triprolidine HCl 1.25mg;
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
357 BRU10020414P Sunadine Syrup Loratadine 5mg/5ml Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
P
358 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
359 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
360 BRU10020417P Isosorbide Dinitrate Tablet 10mg Isosorbide Dinitrate BP 10mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
361 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
362 BRU10020419P Adalat® LA 20 Tablet Nifedipine 20mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
363 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
364 BRU10030423P Rhinathiol 5% Adult Expectorant
Syrup
Carbocisteine 5g/100ml Unither Liquid Manufacturing, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
P
BDMCA/RMP/1116 Page 21 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
365 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mg Instituto De Angeli S.R.L., Italy Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
366 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
370 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
371 BRU10030432P Cisplatin 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
372 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
373 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
374 BRU10030436NP Maalox® Plus Suspension Per 5ml - Aluminium hydroxide 225mg;
Magnesium hydroxide 200mg; Simethicone
USP 25mg
Sanofi Aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05
Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
396 BRU10050463P Nebido 1000mg/4ml, Solution for
Injection
Testosterone undecanoate 250mg(equiv.
to testosterone 157.9mg)
Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
397 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5ml Boehringer Ingelheim, France Hongkiat Trading & Company 06 October 2015 till 05
October 2020
P
398 BRU10050466NP Uphamol Suspension 250
(Orange)
Paracetamol 250mg/5ml Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
GSL (60mL); P
(3.8L)
399 BRU10050467P Taxotere® 20mg/0.5ml
Concentrate and solvent for
solution for Infusion
Docetaxel 20mg/0.5ml (as trihydrate) Sanofi-Aventis Deutschland GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
400 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
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
402 BRU10050471P Zyvox Infusion Bag 600mg/300ml Linezolid 600mg/300ml Fresenius Kabi Norge As, Norway Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 23 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
406 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
407 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
409 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
410 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
411 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate) 10mg/Ml Zoetis P&U LLC, Kalamazoo, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
412 BRU10060484P Miacalcic 50IU Ampoules Salmon calcitonin, synthetic 50IU/1ml Novartis Pharma Stein AG, Switzerland. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
416 BRU10060488P Lescol capsule 40mg Fluvastatin (as the sodium salt) 40mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
417 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
418 BRU10060490P Lescol capsule 20mg Fluvastatin (as the sodium salt) 20mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
421 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
422 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
423 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing, France. Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
424 BRU10060496P Stilnox 10mg film-coated tablet Zolpidem tartrate 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
Sanofi-Aventis Pakistan Limited, Pakistan Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
434 BRU10070507P Miacalcic® Nasal Spray 200IU Salmon calcitonin, synthetic 200IU Delpharm Huningue S.A.S., Switzerland. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
435 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mg Pfizer Australia Pty. Ltd., NSW Australia. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
451 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
452 BRU10080528P Imovane 7.5mg Tablet Zopiclone 7.5mg Aventis International France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
453 BRU10080529P Nasacort Aqueous Nasal Spary Triamcinolone Acetonide 55mcg/actuation Aventis Pharma UK Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
454 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mg Novartis Pharmaceuticals SA Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
462 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
463 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
464 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
BDMCA/RMP/1116 Page 26 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
472 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
473 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
474 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
475 BRU10090552P Harnal OCAS 400mcg Film-coated
tablet
Tamsulosin (as hydrochloride 400mcg)
367mcg
Astellas Pharma Europe BV, The
Netherlands
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
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
491 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
492 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals USA Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
493 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
494 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
495 BRU10100576P Albutein® Solution for Infusion
25%
Albumin (Human) 25% Grifols Biologicals Inc., USA Hongkiat Trading & Company 28 October 2015 till 27
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
497 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
506 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
507 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
508 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
509 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
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
521 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mg Astellas Pharma Europe B.V., The
Netherlands
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
BDMCA/RMP/1116 Page 29 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
522 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
523 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
524 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
525 BRU10120614P Clomid Tablet 50mg Clomifene Citrate 50mg Patheon France S.A., France Medipharm Sdn Bhd 29 December 2015 till 28
December 2020
POM
526 BRU10120615P FlixotideTM EvohalerTM 125mcg Fluticasone propionate 125mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
533 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
534 BRU11010626NP Poro Tablet 500mg Paracetamol 500mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 January 2016 till 25
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
539 BRU11010632P Comtan® Tablet 200mg Entacapone 200mg Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
540 BRU11010633P DF118 Tablet Dihydrocodeine GlaxoSmithKline South Africa (Pty) Ltd.,
South Africa
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
541 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
542 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
POM
BDMCA/RMP/1116 Page 30 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
543 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
Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
557 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
558 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
559 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
BDMCA/RMP/1116 Page 31 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
560 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
561 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
562 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
563 BRU11020658P Zendhin 150 Tablet Ranitidine (as hydrochloride) 150mg Drug House of Australia (Asia) Pte Ltd.,
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
565 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
566 BRU11030661P Primperan® 10mg Suppositories Metoclopramide 10mg Unither Liquid Manufacturing, France. Medipharm Sdn Bhd 26 March 2016 till 25 March
2021
POM
567 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
568 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
569 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
570 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
571 BRU11030668P Vivaxim Suspension and Solution
for Suspension for Injection
Inactivated Hepatitis A Virus, GBM strain
160 antigen units
Sanofi Pasteur, Parc industriel d'Incarville,
France
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
572 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
573 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
574 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
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
576 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
BDMCA/RMP/1116 Page 32 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
577 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
578 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
579 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
580 BRU11040677P Vaxigrip Suspension for Injection Split influenza virus*, inactivated
containing antigens equivalent to the
following strains per one 0.5ml dose:
A/California/7/2009 (H1N1)pdm09-derived
strain used NYMC X-179A) 15mcg HA**;
A/Texas/50/2012(H3N2)-derived strain
used NYMC X-223A 15mcg HA**;
B/Massachusetts/2/2012-derived strain
used NYMC BX-51B 15mcg HA**
Note - * Propagated in fertilized hens’ egg
from healthy chicken flocks
** haemagglutinin
Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
581 BRU11040678P Euvax B Adult Vaccine
Recombinant
Purified HBs-Ag 20mcg LG Life Science Ltd., Korea Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
582 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
583 BRU11040680P Puregon® 50IU/0.5ml Solution for
Injection
Follitrophin Beta (recombinant follicale-
stimulating hormone (FSH) 50IU/0.5ml
N.V.Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
584 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
Octreotide 10mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
587 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
588 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/1116 Page 33 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 30 April 2016 till 29 April
2021
POM
590 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
591 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
Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
613 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
614 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
615 BRU11060717P Protaxos 2g Strontium Ranelate 2632mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
616 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
617 BRU11060719P Amlodipine Winthrop Tablet 5mg Amlodipine (as besilate) Unichem Laboratories Limited, Goa, India Medipharm Sdn Bhd 02 July 2016 till 01 July 2021 POM
618 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
619 BRU11060721P Atorvastatin Winthrop® 40mg
Tablet
Atorvastatin 40mg (as Calcium 41.36mg) Zentiva k.s., Czech Republic Medipharm Sdn Bhd 02 July 2016 till 01 July 2021 POM
620 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
621 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
622 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mg Astella Pharma Europe B.V., The
Netherlands
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
BDMCA/RMP/1116 Page 35 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
623 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
624 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
625 BRU11070730P Mirena® Intrauterine System
20mcg/24hr
Levonorgestrel 52mg Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
626 BRU11070731P Amlodipine Winthrop® 10mg
Tablet
Amlodipine 10mg (as besilate) Unichem Laboratories Limited, Goa, India Medipharm Sdn Bhd 27 July 2016 till 26 July 2021 POM
627 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
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
629 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
630 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
631 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
632 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
633 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
634 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
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
636 BRU11070741P Coralan® Tablet 2.5mg 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
637 BRU11080742P Aclasta 5mg/10ml Solution for
Infusion
Zolendranic acid (anhydrous) 5mg (as
zolendranic acid monohydrate 5.33mg)
Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
640 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
641 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
642 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
643 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydrate Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
645 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
646 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
GlaxoSmithKline Biologicals SA, Belgium Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
648 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
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
652 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
653 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
654 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
Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
662 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
663 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
BDMCA/RMP/1116 Page 38 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
664 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
665 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
666 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
667 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
668 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
669 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
670 BRU11090777P Solian® 100mg Scored Tablet Amisulpiride 100mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 27 September 2016 till 26
September 2021
POM
671 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
672 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mg Bushu Pharmaceuticals Ltd, Japan. , Japan MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
673 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mg Bushu Pharmaceuticals Ltd, Japan. , Japan MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
674 BRU11100781P Puregon® 100IU/0.5ml Solution
for Injection
Follitropin beta (recombinant follicle-
stimulating hormone - FSH) 100IU/0.5ml
N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
675 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
676 BRU11100783P TypherixTM Vi Polysccharide
Typhoid Vaccine 25mcg/0.5ml
Vi Polysaccaharide of Salmonella Typhi GlaxoSmithKline Biologicals SA, Rixensart
Belgium; GlaxoSmithKline Biologicals S.A.,
Wavre Belgium; Sächsisches Serumwerk
Dresden
Branch of SmithKline Beecham Pharma
GmbH & Co. K.G., Dresden
Germany; GlaxoSmithKline Biologicals,
Saint Amand Les Eaux France
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
677 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
678 BRU11100785P Atorvastatin Winthrop® 10mg
film-coated Tablets
Atorvastatin 10mg (as calsium 10.34mg) Zentiva k.s., Czech Republic MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
679 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
BDMCA/RMP/1116 Page 39 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
680 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
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
682 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mg Eisai Co., Ltd, Saitama Prefecture, Japan MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
683 BRU11100790P VarilrixTM Live attenuated varicella virus (OKA strain) GlaxoSmithKline Biologicals SA, Rixensart,
Belgium (Manufacturer of finished
product); 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
684 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
685 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
686 BRU11100793P Solian® 400mg Scored Tablet Amisulpride 400mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
687 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
688 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
689 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
690 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
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
711 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
712 BRU11120821P MencevaxTM ACWY Vaccine (1
Dose)
Per 0.5ml : Meningococcal purified
polysaccharides of: Serogroup A - 50mcg,
Serogroup C - 50mcg Serogroup W135 -
50mcg Serogroup W135 - 50mcg Serogroup
Y - 50mcg
GlaxoSmithKline Biologicals SA, Rixensart
Belgium
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
713 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/1116 Page 42 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
714 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
715 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
716 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
GSL
717 BRU11120827P Methycobal Injection 500mcg/ml Mecobalamin 500mcg Bushu Pharmaceuticals Ltd, Japan MediPharm Sdn Bhd 22 December 2016 till 21
December 2021
POM
718 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
719 BRU11120829NP Shintamet film coated Tablet Cimetidine 400mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2011 till 21
December 2016
POM
720 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
721 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
Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
724 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
725 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
726 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2011 till 21
December 2016
POM
727 BRU11120837P Primacor® 10mg/10ml Injection Milrinone 10mg/10ml (as lactate) Sanofi Winhtrop Industrie, France MediPharm Sdn Bhd 22 December 2016 till 21
December 2021
POM
728 BRU11120838NP Champs D-Worms 6 Chewable
Tablet (Chocolate)
Albendazole 200mg Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 22 December 2011 till 21
December 2016 (PL
extended to 26 March 2017)
GSL (2's)
729 BRU11120839P Epilim® 200 Enteric Coated
Tablets
Sodium Valproate 200mg Sanofi-Synthelabo Ltd., United Kingdom MediPharm Sdn Bhd 22 December 2016 till 21
December 2021
POM
BDMCA/RMP/1116 Page 43 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
736 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
737 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd 01 February 2017 till 31
January 2022
P
742 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 2012 till 31
January 2017
GSL
BDMCA/RMP/1116 Page 44 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
743 BRU12010853P Concor® 5mg tablet Bisoprolol hemifumarate 5mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
744 BRU12010854P Ketipinor film-coated tablet
100mg
Quetiapine (as fumarate 115.13mg) 100mg Orion Corporation, Finland Hongkiat Trading & Co 01 February 2012 till 31
January 2017 (PL extended
to 26 March 2017)
POM
745 BRU12010855P Euthyrox® Tablet 50mg Levothyroxine sodium 50mcg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
747 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml (200mg/vial) Gruppo Lepetit S.r.I., Italy MediPharm Sdn Bhd 01 February 2017 till 31
January 2022
POM
748 BRU12020858P Sebivo™ Tablet 600mg Telbivudine 600mg Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
749 BRU12020859P Esonide Nasal Spray
100mcg/dose
Budesonide 2mg/ml equivalent to
100mcg/dose
Kleva S.A., Greece G & H Trading Company 29 February 2012 till 28
February 2017
POM
750 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 29 February 2012 till 28
February 2017
POM
751 BRU12020861P Thyrozol® 20mg Film-coated
Tablets
Thiamazole 20mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
752 BRU12020862P Ketipinor Film-coated Tablet
25mg
Quetiapine (as fumarate 28.78mg) 25mg Orion Corporation, Finland Hongkiat Trading & Co 29 February 2012 till 28
February 2017 (PL extended
to 26 March 2017)
POM
753 BRU12020863P Taxotere 20mg/1ml concentrate
for solution for infusion
Docetaxel (as trihydrate) 20mg/ml Sanofi-Aventis Deutschland GmbH,
Germany
MediPharm Sdn Bhd 29 February 2012 till 28
February 2017
POM
754 BRU12020864P Zanidip® Tablet 10mg Lercanidipine Hydrochloride 10mg (eq. to
9.4mg Lercanidipine)
Recordati Industria Chimica &
Farmaceutica S.p.A, Italy
Hongkiat Trading & Co 29 February 2012 till 28
February 2017 (PL extended
to 26 March 2017)
POM
755 BRU12020865PS1 &
BRU12020865PS2
Nifedipine LA Tablet 30mg Nifedipine 30mg Valpharma International S.p.A, Italy (S1);
Valpharma S.A, Italy (S2)
G & H Trading Company 29 February 2012 till 28
February 2017
POM
756 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
757 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 March 2017 till 29 March
2022
POM
773 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
774 BRU12040885P Jevtana® 60mg Concentrate and
Solvent for Solution for Infusion
Cabazitaxel 60mg/1.5ml Sanofi-Aventis Deutschland GmbH,
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
781 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)
782 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
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
784 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
785 BRU12040896P Niquitin 21mg Transdermal Patch Nicotine 114mg (delivers 21mg/24 hours) ALZA Corporation, California, USA Zuellig Pharma (B) Sdn Bhd 30 April 2012 till 29 April
2017
P
786 BRU12050897P VfendTM IV 200mg Voriconazole 200mg Pharmacia & Upjohn Company, USA
(Repacker - Pfizer PGM, France)
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM
815 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
816 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
817 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
818 BRU12080929P Niquitin 14mg Transdermal Patch Nicotine 78mg (14mg/24hrs) Alza Corporation, California, USA Zuellig Pharma (B) Sdn Bhd 29 August 2012 till 28 August
2017
P
819 BRU12080930NP Dequadin® Lozenges (Citrus
Flavour)
Dequalinium Chloride 0.25mg Sterling Drug (Malaya) Sdn Bhd., Selangor,
Malaysia
Kingston Beverage & Creamery
Sdn Bhd
29 August 2012 till 28 August
2017
GSL (6x4's & 24's)
820 BRU12080931P Rilutek Tablets 50mg Riluzole 50mg Sanofi Winthrop Industrie, Cedex, France Medipharm Sdn Bhd 29 August 2012 till 28 August
Hongkiat Trading & Company 27 November 2012 till 26
November 2017
GSL
845 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)
Medipharm Sdn Bhd 27 November 2017 till 26
November 2022
POM
846 BRU12110958P Tretino Cream 0.05% Tretionoin (Retinoic acid) 0.5mg/g Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 November 2012 till 26
November 2017
POM
847 BRU12110959P Eprex® 2000 Prefilled Syringe
2000IU/0.5ml
Epoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26
November 2017
POM
BDMCA/RMP/1116 Page 50 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
848 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mg Les Laboratories Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26
Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26
December 2017
POM
860 BRU12120973P ZyrprexaTM
Tablet 10mg Olanzapine 10mg Lily del Caribe Inc, Puerto Rico, USA & Lilly
S.A., Madrid, Spain
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
861 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
BDMCA/RMP/1116 Page 51 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
862 BRU12120975P Stelara Solution for Injection in
Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
BDMCA/RMP/1116 Page 53 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
898 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, Malaysia G & H Trading Company 26 February 2013 till 25
February 2018
POM
899 BRU13021014P Progynova® Tablet 2mg Estradiol Valerate 2mg Delpharm Lille SAS, Lys Les Lannoy, Franc Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
900 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 26 February 2013 till 25
920 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 2013 till 27 March
2018
POM
921 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
922 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 2013 till 27 March
2018
POM
923 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 28 March 2013 till 27 March
2018
POM
924 BRU13031040P Indapamide SR Tablet 1.5mg Indapamide 1.5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 28 March 2013 till 27 March
2018
POM
925 BRU13031041P Dhatifen Syrup 1mg/5ml Ketotifen (as hydrogen fumarate) 1mg/5ml Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 28 March 2013 till 27 March
2018
POM
926 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2013 till 27 March
2018
POM
927 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2013 till 27 March
2018
POM
928 BRU13031044P Zenmolin tablet 2mg Salbutamol (as sulphate) 2mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 28 March 2013 till 27 March
2018
POM
929 BRU13031045P Recormon Pre-filled Syringe
2000IU/0.3ml
Erythropoetin Beta 2,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
930 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
931 BRU13031047P Recormon Pre-filled Syringe
4000IU/0.3ml
Erythropoetin Beta 4,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
932 BRU13031049P Saizen for Injection 3.33mg/vial Somatropin 3.33mg (10 IU) Merck Serono S.A., Switzerland G & H Trading Company 28 March 2013 till 27 March
940 BRU13041057P Fucithalmic® Eye Drops 1% Fusidic acid 10mg/g (1.0%w/w) LEO Laboratories Ltd, Dublin, Ireland Zuellig Pharma (B) Sdn Bhd 30 April 2013 till 29 April
2018
POM
941 BRU13041058P Pegasys Pre-filled Syringe
180mcg/0.5ml
Peginterferon alfa-2a 180mcg/0.5ml F Hoffman-La Roche Ltd, Switzerland;
Roche Diagnostic GmbH, Germany; F
Hoffman-La Roche Ltd, Betriebsstandort
Kaiseraugst (Parenterals), Switzerland
Hongkiat Trading & Co 30 April 2013 till 29 April
2018
POM
942 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 April 2013 till 29 April
2018
POM
943 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Roche S.p.A., Italy Hongkiat Trading & Co 30 April 2013 till 29 April
946 BRU13041063P Apuzin tablet 25mg Captopril 25mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 April 2013 till 29 April
2018
POM
947 BRU13041064P Lezpain film-coated tablet 135mg Mebeverine HCl 135mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 April 2013 till 29 April
949 BRU13041066P Celexin 250 Film-coated Tablet Cephalexin 250mg (as monohydrate) Hovid Bhd, Malaysia K-Seri Pharma Sdn Bhd 30 April 2013 till 29 April
2018
POM
950 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, Germany Hongkiat Trading & Co 30 April 2013 till 29 April
Pazopanib (as hydrochloride) 200mg Glaxo Operations UK Ltd, Hertfordshire,
UK
Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
953 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)
Medipharm Sdn Bhd 04 June 2013 till 03 June
2018
POM
954 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mg Abbott Biologicals B.V., The Netherlands Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
BDMCA/RMP/1116 Page 56 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
955 BRU13061072NP Nutravit™ Syrup Per 5ml - Riboflavine 1.46mg; Calcium
Pantothenate 3.25mg; Ascorbic Acid
17.5mg; Vitamin A 4000iu; Vitamin D
400iu; Nicotinamide 10.00mg; Lysine HCl/
Monochloride 100.00mg; Thiamine HCl/
Vit. B1 2.00mg; Cynocobalamine/ Vit B12
1.5mcg; Pyridoxine HCl/Vit B6 2.00mg
Hovid Bhd, Malaysia G & H Trading Company 04 June 2013 till 03 June
957 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, France Hongkiat Trading & Co 04 June 2013 till 03 June
2018
POM
958 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 2013 till 03 June
2018
POM
959 BRU13061076P Xeloda™ Tablets 500mg Capecatibine 500mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
960 BRU13061077P Chloramphenicol Eye Ointment Chloramphenicol 10mg/g KRKA d.d., Slovenia K-Seri Pharma Sdn Bhd 04 June 2013 till 03 June
962 BRU13061079NP Maltofer® Syrup Iron (III) [as Iron (III)-hydroxide-
polymaltose complex] 10mg/ml
Vifor S.A., Switzerland & Vifor
(International) Inc., Switzerland
Medipharm Sdn Bhd 04 June 2013 till 03 June
2018
GSL
963 BRU13061080P Noriday® Tablet Norethisterone 0.35mg Piramal Healthcare UK Limited, United
Kingdom
Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
964 BRU13061081P Keppra 250mg Film-coated Tablet Levetiracetam 250mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
965 BRU13061082P Keppra 500mg Film-coated Tablet Levetiracetam 500mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
966 BRU13061083PS1,
BRU13061083PS2,BRU13
061083PS3,
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)
Medicare 04 June 2013 till 03 June
2018
POM
967 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
968 BRU13061085P Uripax Film-coated Tablet 200mg Flavoxate HCl 200mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
969 BRU13061086P Atorvas Tablets 10mg Atorvastatin (as calcium) 10mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 04 June 2013 till 03 June
Ciprofloxacin 0.2% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2013 till 26 June
2018
POM
974 BRU13061091NP Infusol® W Intravenous Infusion
BP
Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2013 till 26 June
2018
GSL
975 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml (0.1%) EVER Pharma Jena GmbH, Germany Zuellig Pharma (B) Sdn Bhd 27 June 2013 till 26 June
2018
POM
976 BRU13061093P Invoril tablets 10mg Enalapril maleate 10mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 27 June 2013 till 26 June
Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
986 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 July 2013 till 29 July 2018 POM
987 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 2013 till 29 July 2018 POM
988 BRU13071105P Lignocaine Injection 2% x 5ml Lignocaine Hydrochloride 20mg/ml Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
994 BRU13071111P Micosten-H Cream Miconazole Nitrate 2%; Hydrocortisone 1% Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 30 July 2013 till 29 July 2018 POM
G & H Trading Company 30 July 2013 till 29 July 2018 POM
996 BRU13071113P Hydralazine Tablet 10mg Hydralazine Hydrochloride 10mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 July 2013 till 29 July 2018 POM
997 BRU13071114P Sandimmun Neoral Capsule 25mg Ciclosporin A 25mg R.P. Scherer GmbH & Co. KG., Germany Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August
2018
POM
1002 BRU13081119PS1;
BRU13081119PS2
Zoral Cream Acyclovir USP 5% w/w Drug Houses of Australia Private Limited,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 27 August 2013 till 26 August
2018
POM
1003 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 2013 till 26 August
2018
POM
1004 BRU13081121P Xenical Capsule 120mg Orlistat 120mg Roche SpA, Italy Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August
2018
POM
1005 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August
2018
POM
1006 BRU13081123P Minazol Powder 2% Miconzaole Nitrate 2% w/w Biosis Pharmaceuticals Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 27 August 2013 till 26 August
2018
P
1007 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine) 5,000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 August 2013 till 26 August
Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
1014 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
1015 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 2013 till 27
September 2018
POM
1016 BRU13091134P Pantaprazole Winthrop 40mg
Tablet
Pantoprazole (as sodium Sesquihydate)
40mg
Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 28 September 2013 till 27
September 2018
POM
1017 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 2013 till 27
September 2018
P
1018 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
1019 BRU13091137P Effient Tablet 5mg Prasugrel HCl 5mg Eli Lilly & Co., USA Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
1020 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 2013 till 27
September 2018
POM
1021 BRU13091139P Simvastatin Winthrop 40mg
Tablet
Simvastatin 40mg Sanofi Aventis S.p.z.o.o, Poland Medipharm Sdn Bhd 28 September 2013 till 27
September 2018
POM
1022 BRU13091140P Camazol Tablet 5mg Carbimazole 5mg Xepa-Soul Pattinson (M) Sdn Bhd
Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
BDMCA/RMP/1116 Page 60 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1030 BRU13101148P Eumovate™ Cream Clobetasone 17-butyrate 0.05% w/w Glaxo Wellcome Opration, UK Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31
October 2018
POM
1031 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 2013 till 31
October 2018
POM
1032 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
Asterix United (B) Sdn Bhd 02 December 2013 till 01
December 2018
POM
1053 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 2013 till 01
December 2018
POM
1054 BRU13121173NP Refresh Tears Lubricant Eye
Drops 0.5%
Carboxymethylcellulose Sodium 0.5% w/v Allergan Sales LLC, USA Medipharm Sdn Bhd 02 December 2013 till 01
December 2018
GSL
1055 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 02 December 2013 till 01
December 2018
POM
1056 BRU13121176PS1 &
BRU13121176PS2
Dhasolone Tablet 5mg Prednisolone BP (micronized) 5mg Drug Houses of Australia Private Limited,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 02 December 2013 till 01
December 2018
POM
1057 BRU13121177P Cyclogyl® 1% Sterile Ophthalmic
Solution (T)
Cyclopentolate Hydrochloride 1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 December 2013 till 01
December 2018
POM
1058 BRU13121178P Betawin Tablet 50mg (T) Metoprolol Tartrate 50mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co 02 December 2013 till 01
December 2018
POM
1059 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29
December 2018
POM
1060 BRU13121180P Glucovance Tablet 500mg/5mg Metformin HCl 500mg; Glibenclamide 5mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29
December 2018
POM
1061 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 2013 till 29
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 28 January 2014 till 27
January 2019
GSL
1081 BRU14011201P Prefrin Liquifilm Eye Drops 0.12% Phenylephrine Hydrochloride 0.12% Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27
January 2019
P
BDMCA/RMP/1116 Page 63 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1082 BRU14011202NP Refresh Liquigel Lubricant Eye
Drops 1%
Carboxymethylcellulose Sodium 1% w/v Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27
January 2019
GSL
1083 BRU14011203P Betaserc 24mg Tablet Betahistine dihydrochloride 24mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1084 BRU14011204PS1;
BRU14011204PS2
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); Eli Lilly
Italia S.p.A., Sesto Fiorentino, (FI) Italy
(S2) (repacker -
Eli Lilly And Company, USA) & Eli Lilly Italia
S.p.A., Sesto Fiorentino, (FI) Italy;
Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
1090 BRU14011210P Axcel Famotidine-20 Capsule Famotidine 20mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd, Malaysia 28 January 2014 till 27
January 2019
POM
1091 BRU14011211NPS1;
BRU14011207PS2
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 2014 till 27
January 2019
GSL
1092 BRU14011212P Axcel Chlorpheniramine-4 Syrup Chlorpheniramine Maleate 4mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd, Malaysia 28 January 2014 till 27
January 2019
P
1093 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 2014 till 27
January 2019
POM
1094 BRU14021214P Panaflex Extra Gel Diclofenac Sodium 10mg/1gm United Biomedical Inc., Asia, Taiwan Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
GSL
BDMCA/RMP/1116 Page 66 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1117 BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1118 BRU14021238NP Axcel Dicyclomine-S Syrup Per 5mL: Dicyclomine hydrochloride 5mg
and Simethicone 50mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
GSL
1119 BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin (recombinant DNA
origin) Biosynthetic
Eli Lilly an Company, USA Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1120 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 2014 till 26
February 2019
GSL
1121 BRU14021241P Giona Easyhaler 200mcg/dose
Inhalation Powder
Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading & Co 27 February 2014 till 26
February 2019
POM
1122 BRU14021242P Amoxicillin Capsule 500mg Amoxicillin Trihydrate 500mg Yung Shin Pharmaceutical Ind. Co., Taiwan Asterix United (B) Sdn Bhd 27 February 2014 till 26
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
POM
1129 BRU14031249P Tygacil 50mg Lyophilised Powder
for Intravenous Infusion
Tigecycline 50mg Wyeth Lederle S.r.L, Italy Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1130 BRU14031250PS1;BRU14
031250PS2
Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml (equivalent to
14.2mg
Novo Nordisk A/S, Denmark (S1); Novo
Nordisk Producao Farmaceutica do Brasil
Ltda., Brazil (S2)
MediPharm Sdn Bhd 27 March 2014 till 26 March
2019
POM
1131 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 2014 till 26 March
2019
POM
1132 BRU14031252P Stalevo 200/50/200mg Film-
coated Tablet
Levodopa 200mg; Carbidopa 50mg;
Entacapone 200mg
Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1133 BRU14031253P Humulin N Injection 100iu/vial Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
BDMCA/RMP/1116 Page 67 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1134 BRU14031254NP Nutrineal PD-4 with 1.1% Amino
Acid Solution
Each 1000ml contains L-Serine 0.510g; L-
Isoleucine 0.850g; L-Leucine 1.020g; L-
Lysine (as Hydrochloride) 0.955g; L-
Methionine 0.850g; L-Phenylalanine
0.570g; L-Threonine 0.646g; L-Tryptophan
0.270g; L-Valine 1.393g; L-Alanine 0.951g; L-
Arginine 1.071g; Glycine 0.510g; L-Histidine
0.714g; L-Proline 0.595g; L-Tyrosine 0.300g;
Sodium Chloride 5.380g; Calcium Chloride
Dihydrate 0.184g; Magnesium Chloride
Hexahydrate 0.051g; Sodium Lactate 4.48g
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 27 March 2014 till 26 March
2019
POM
1135 BRU14031255P Effient™ Tablet 10mg Prasugrel (as hydrochloride) 10mg Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1136 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 2014 till 26 March
2019
POM
BDMCA/RMP/1116 Page 68 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1137 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 2014 till 26 March
2019
POM
1138 BRU14031258P Volibris 5mg Film-coated Tablet Ambrisentan 5mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1139 BRU14031259P Volibris 10mg Film-coated Tablet Ambrisentan 10mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1140 BRU14031260P Atarax™ Syrup 2mg/ml Hydroxyzine hydrochloride 2mg/ml NextPharma SAS, France Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1141 BRU14031261P Prograf Capsule 1mg Tacrolimus 1mg Astellas Ireland Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1142 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
1143 BRU14031263P Patanol® Eye Drops, Solution
0.1%
Olopatadine (as HCl) 0.1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Company 27 March 2014 till 26 March
Hongkiat Trading & Company 27 March 2014 till 26 March
2019
POM
1145 BRU14031265P Chlorpheniramine tablet 4mg Chlorpheniramine Maleate 4mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
POM
1146 BRU14031266P Allertyn Tablet 10mg Loratadine (micronized) 10mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
P
1147 BRU14031267P Motilium Suspension 1mg/ml Domperidone 1mg/ml Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
BDMCA/RMP/1116 Page 71 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1174 BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1175 BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1176 BRU14041296P Shincort IM Injection “Yung Shin”
Hongkiat Trading & Company 26 April 2014 till 25 April
2019
POM
1178 BRU14041298P Chlormine Syrup 4mg/5ml Chlorpheniramine Maleate 4mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
P
1179 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
1180 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
1181 BRU14041301P DermovateTM Ointment Clobetasol Propionate 0.05% w/w Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2014 till 25 April
2019
POM
1185 BRU14041305NP Lactul Solution 670mg/ml Lactulose 670mg/ml Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 April 2014 till 25 April
2019
GSL
1186 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
1187 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 2014 till 25 April
Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1193 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
BDMCA/RMP/1116 Page 72 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
Sodium Chloride 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
GSL
1195 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
1196 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
1197 BRU14041317P Rozidal Tablet 1mg Risperidone 1mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G&H Trading Company 26 April 2014 till 25 April
2019
POM
1198 BRU14071318PS1 &
BRU14071318PS2
Rebif ® 44 Pre-filled Syringe
44mcg/0.5ml
Interferon-beta-1a (12MIU) 44mcg/0.5ml Merck Serono S.p.A., Italy G & H Trading Company 02 July 2014 till 01 July 2019 POM
1199 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)
Medipharm Sdn Bhd 02 July 2014 till 01 July 2019 POM
1200 BRU14071320P Protopic® Ointment 0.3% Tacrolimus 0.3mg/g (0.3%) Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1202 BRU14071322P Nootropil 1200mg Tablet Piracetam 1200mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1203 BRU14071323P Nootropil 800mg Tablet Piracetam 80mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1204 BRU14071324P Luvox® Film-coated Tablets 50mg Fluvoxamine maleate 50mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1205 BRU14071325P Luvox® Film-coated Tablets
100mg
Fluvoxamine maleate 100mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1206 BRU14071326P TobraDex® Eye Ointment Tobramycin 0.3%, Dexamethasone 0.1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1207 BRU14071327P AgrippalTM S1, Suspension for
Injection in pre-filled syringe
Per 0.5ml dose: Split influenza virus*,
inactivated, containing antigens equivalent
to the following strains:
A/California/07/2009 (H1N1) pdm09– like
strain -15μg HA** (A/California/07/2009,
NYMC X-181);
A/Texas/50/2012 (H3N2) – like strain 15μg
HA**, A/Texas/50/2012, NYMC X-223-;
B/Massachusetts/2/2012– like strain
15μgHA** B/Florida/4/2006 wild type.
Novartis Vaccines and Diagnostic S.r.L.,
Italy
Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1208 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1209 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 2014 till 01 July 2019 GSL
BDMCA/RMP/1116 Page 73 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1210 BRU14071330PS1;
BRU14071330PS2
Humalog Kwikpen 100units/ml Insulin Lispro 100units/ml Lilly France S.A.S., France (S1); Eli Lilly
Italia S.p.A., Sesto Fiorentino, (FI) Italy
(S2) (repacker -
Eli Lilly And Company, USA) & Eli Lilly Italia
S.p.A., Sesto Fiorentino, (FI) Italy;
Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1211 BRU14071331P Shincort IM Injection "Yung Shin"
Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1214 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 POM
1215 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 2014 till 01 July 2019 POM
1216 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w 3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1217 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mg Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1218 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
1219 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
1220 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
1221 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
1222 BRU14071342P Axcel Ibuprofen Paediatric Syrup Ibuprofen 100mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 P
G & H Trading Company 02 July 2014 till 01 July 2019 GSL
1224 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1225 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1226 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 2014 till 01 July 2019 POM
1227 BRU14071347P Invoril Tablet 5mg Enalapril Maleate 5mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 02 July 2014 till 01 July 2019 POM
G & H Trading Company 02 July 2014 till 01 July 2019 POM
BDMCA/RMP/1116 Page 74 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1229 BRU14071349P Dhacodine Syrup 15mg/5ml Pholocodine 15mg/5ml Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1230 BRU14071350P Roaccutane Capsules 20mg Isotretinion 20mg R P Scherer GmbH & Co KG., Germany Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1231 BRU14071351P Roaccutane Capsule 10mg Isotretinion 10mg R.P. Scherer GmbH & Co. KG., Germany Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1232 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1240 BRU14071360P Maxidex Sterile Opthalmic
Suspension
Dexamethasone 0.1% ( 1mg/ml) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1241 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
1242 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
1243 BRU14071363P Dormicum Injection 15mg/3ml Midazolam 15mg/3ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1244 BRU14071364P Dormicum Injection 5mg/5ml Midazolam 5mg/5ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1245 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
Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1247 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 2014 till 01 July 2019 POM
BDMCA/RMP/1116 Page 75 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1248 BRU14071368P Yondelis® Powder for Injection
1mg/vial
Trabectedin 0.05mg/ml Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1249 BRU14071369P Trajenta film-coated tablet 5mg Linagliptin 5mg Boehringer Ingelhein Roxane Inc., USA Hongkiat Trading & Company 24 July 2014 till 23 July 2019 POM
1250 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 Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM
1251 BRU14071371P NovoSeven 5mg/vial, Powder and
Solvent for Solution for Injection
Eptacog alfa (activated) 5mg/vial
(corresponds to 250KIU/vial) - 1mg/ml
after reconstitution
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM
1252 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 2014 till 23 July 2019 POM
1253 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 2014 till 23 July 2019 POM
1254 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 2014 till 23 July 2019 POM
1255 BRU14071375P Lucentis 10mg/ml Solution for
Injection
Ranibizumab 10mg/ml Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1256 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 2014 till 23 July 2019 POM
1257 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 2014 till 23 July 2019 POM
1258 BRU14071378P Requip PD 24hr Prolong Release
Tablet 2mg
Ropinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1259 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 2014 till 23 July 2019 GSL
1260 BRU14071380P Vfend Powder For Oral
Suspension 40mg/ml
Voriconazole 40mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1261 BRU14071381P Norditropin® Nordilet® Solution
for Injection 10mg/1.5ml
Somatropin (biosynthetic human growth
hormone) 10mg/1.5ml
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM
1262 BRU14071382P Alphagan P Ophthalmic Solution
0.15%
Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM
1263 BRU14071383P Mapenem® IV Injection 500mg Meropenem 500mg (as trihydrate) Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 24 July 2014 till 23 July 2019 POM
1264 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 2014 till 23 July 2019 POM
1265 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
BDMCA/RMP/1116 Page 76 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1270 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 24 July 2014 till 23 July 2019 POM
1271 BRU14071391P Lamictal Tablet 50mg Lamotrigine 50mg Glaxosmithkline Pharmaceuticals SA,
Poland
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1275 BRU14071395P Axcel Metronidazole-400 Tablet Metronidazole 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 24 July 2014 till 23 July 2019 POM
1276 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1277 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)
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1278 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 24 July 2014 till 23 July 2019 POM
1279 BRU14071399P Vigamox® Ophthalmic Solution
0.5%
Moxifloxacin 0.5% (as hydrochloride) Alcon Laboratories, Inc., USA Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM
1280 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
G & H Trading Company 24 July 2014 till 23 July 2019 POM
1288 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1290 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1291 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as Hydrochloride) Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1294 BRU14071414P Garbose Tablet 50mg Acarbose 50mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM
1296 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 2014 till 29 August
2019
POM
1297 BRU14081417P Emend Tri-Pack Capsule Each capsule either contains Aprepitant
80mg or 125mg
Merck Sharp & Dohme Corp. Australia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1298 BRU14081418P Protopic Ointment 0.1% Tacrolimus 0.1% (as monohydrate) Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1299 BRU14081419PS1 &
BRU14081419PS2
Exforge HCT 10/160/12.5mg Film-
coated tablet
Amlodipine 10mg (as besylate); Valsartan
160mg; Hydrochlorothiazide 12.5mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1300 BRU14081420PS1 &
BRU14081420PS2
Exforge HCT 10/160/25mg Film-
coated tablet
Amlodipine 10mg (as besylate); Valsartan
160mg; Hydrochlorothiazide 25mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1301 BRU14081421PS1 &
BRU14081421PS2
Exforge HCT 5/160/12.5mg Film-
coated tablet
Amlodipine 5mg (as besylate); Valsartan
160mg; Hydrochlorothiazide 12.5mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
BDMCA/RMP/1116 Page 78 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1302 BRU14081422PS1 &
BRU14081422PS2
Exforge HCT 5/160/25mg Film-
coated tablet
Amlodipine 5mg (as besylate); Valsartan
160mg; Hydrochlorothiazide 25mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1303 BRU14081423PS1 &
BRU14081423PS2
Exforge HCT 10/320/25mg Film-
coated tablet
Amlodipine 10mg (as besylate); Valsartan
320mg; Hydrochlorothiazide 25mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1304 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 2014 till 29 August
2019
POM
1305 BRU14081425P Lipanthyl Penta 145 Film-Coated
tablet
Fenofibrate 145mg Recipharm Fontaine, France Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
Hongkiat Trading & Co 30 August 2014 till 29 August
2019
POM
1307 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mcg GlaxoWellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1311 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
1312 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
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1313 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vial Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 August 2014 till 29 August
2019
POM
1315 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1316 BRU14081436P Dilatrend Tablet 25mg Carvedilol 25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1317 BRU14081437P Dilatrend Tablet 12.5mg Carvedilol 12.5mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1318 BRU14081438P Dilatrend Tablet 6.25mg Carvedilol 6.25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1319 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
POM
BDMCA/RMP/1116 Page 79 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1320 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
1321 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mg Glaxosmithkline Pharmaceuticals SA,
Poland
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1322 BRU14081442P Axcel Loratadine Tablet Loratadine 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
G & H Trading Company 30 August 2014 till 29 August
2019
P
1324 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
1325 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
1326 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
1327 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
2019
POM
1328 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mg Biosis Pharmaceuticals Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 30 August 2014 till 29 August
2019
POM
1329 BRU14081449P Mircera Pre-filled Syringe
75mcg/0.3ml
Methoxy polyethylene glycol-epoetin Beta
75mcg/0.3ml
Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1330 BRU14081450P Creobic (New Formula) Cream Clotrimazole 1%w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
2019
GSL
1331 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
G & H Trading Company 30 August 2014 till 29 August
2019
POM
1334 BRU14081454P Loxof Tablets 500mg Levofloxacin 500mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
POM
1335 BRU14081455P Proluton Depot 250mg Injection Hydroxyprogesterone Caproate 250mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1336 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
P
1337 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
2019
POM
1338 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1339 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 2014 till 29 August
2019
POM
BDMCA/RMP/1116 Page 80 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1340 BRU14081460P Clarimycin Film Coated Tablet
500mg
Clarithromycin 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1341 BRU14081461NP Mentar Shampoo Coal Tar solution 9% v/v; Menthol 1% w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 August 2014 till 29 August
G & H Trading Company 30 August 2014 till 29 August
2019
GSL
1349 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
1350 BRU14081470P Rotaqor 10mg film-coated tablet Atorvastatin 10mg (as calcium) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1351 BRU14081471P Zoral 200 tablet 200mg Acyclovir USP 200mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 August 2014 till 29 August
2019
POM
1352 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
1353 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
POM
1354 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 2014 till 29 August
HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
GSL
1356 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate) Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1357 BRU14091477P Suprane Inhalation Liquid 100% Desflurane 100% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
1386 BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 September 2014 till 29
Sodium Chloride 0.9% B. Braun Medical Industries Sdn Bhd
Malaysia
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
GSL
1388 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 2014 till 29
September 2019
POM
1389 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 2014 till 29
September 2019
POM
1390 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 2014 till 29
September 2019
POM
1391 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 2014 till 29
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1394 BRU14091518P Axcel Dextromethorphan-30
Syrup
Dextromethorphan Hydrobromide
30mg/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 September 2014 till 29
September 2019
POM
1395 BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1396 BRU14091520P 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
POM
1397 BRU14091521P Ospexin 500mg Film-coated
Tablets
Cefalexin 500mg (as monohydrate) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
BDMCA/RMP/1116 Page 83 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1398 BRU14091522PS1 &
BRU14091522PS2
Androcur Tablet 50mg Cyproterone acetate 50mg Delpharm Lille SAS, France Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1399 BRU14091523P Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 September 2014 till 29
September 2019
GSL
1400 BRU14091524P Melaquin Cream 4% w/w Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
P
1401 BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1402 BRU14091526P Glucomet Tablet 500mg Metformin Hydrochloride 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1403 BRU14091527P Quemox Tablet 500mg Mebendazole 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
Bayer de Mexico SA De CV, Mexico Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1436 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 2014 till 31
October 2019
GSL
1437 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 2014 till 31
October 2019
GSL
1438 BRU14111562NP Strepsils Orange with Vitamin C
Haupt Pharma Munster GmbH., Germany Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1440 BRU14111564P Axcel Promethazine-5 Syrup Promethazine Hydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 01 November 2014 till 31
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1442 BRU14111566P Aggrastat Concentrate for
Infusion 0.25mg/ml
Tirofibon 0.25mg/ml (as hydrochloride
monohydrate 0.281mg/ml)
DSM Pharmaceuticals Inc., USA & Orion
Corporation, Espoo, Finland
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1443 BRU14111567P Promezine Syrup 1mg/ml Promethazine Hydrochloride 1mg/ml Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 01 November 2014 till 31
October 2019
POM
1452 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
1453 BRU14111577NP Dettol Antiseptic Germicide
Liquid
Parachlorometaxylenol 4.8%w/v Pt. Reckitt Benckiser Indonesia Syarikat Aliaa Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1454 BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1455 BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1456 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
Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 87 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1463 BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1464 BRU14111588PS1;
BRU14111588PS2
Humulin R Injection 100IU/ml
(Catridges)
Human Insulin (Recombinant DNA origin)
100IU/ml
Lilly France SAS, France (S1); Eli Lily Italia
S.p.A., Sesto Fiorentino,
(FI) Italy (S2)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1465 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
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1477 BRU14111601NP T3 Pimple Gel Rescorcinol 2% w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1478 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
1479 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
BDMCA/RMP/1116 Page 88 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1480 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
1481 BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May
Azithromycin 200mg Sandoz S.R.L., Romania Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1485 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
POM
1486 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
1487 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
1489 BRU14111613P Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1490 BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1491 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
1492 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
1493 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
1494 BRU14111619P Crixan Tablet 250mg Clarithromycin 250mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1495 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
1496 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
1497 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
1498 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 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 89 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1499 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 2015 till 18 May
2020
POM
1500 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 2015 till 18 May
2020
POM
1501 BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1502 BRU14111627P Cellcept Tablet 500mg Mycophenolate mofetil 500mg Roche S.p.A., Italy Medicare 19 May 2015 till 18 May
2020
POM
1503 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
1504 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
1505 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
1506 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
1507 BRU14111632P Axcel Orlistat 120 Tablet Orlistat 120mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
1509 BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1510 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
1511 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
1512 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
1513 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
1514 BRU14111639P Servidipine 30mg Film-coated
Tablets
Nifedipine 30mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1515 BRU14111640P Servidipine 60mg Film-coated
Tablets
Nifedipine 60mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1516 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
1517 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
BDMCA/RMP/1116 Page 90 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1518 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
1519 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
1520 BRU14111645P 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
SWL Biomed Sales & Services 19 May 2015 till 18 May
2020
GSL
1522 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
1524 BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1525 BRU14111650P Invokana Film-coated Tablet
100mg
Canagliflozin 100mg (as hemihydrate) Janssen-Cilag SpA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1526 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
1527 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
Paracetamol 10mg/ml i) Fresenius Kabi Germany AB ii) Fresenius
Kabi Austria
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1530 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
1531 BRU14111656P Visudyne Injection Verteprofin 15mg Par Sterile Products LLC, United States Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1532 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
1533 BRU14121662P Ipolipid Capsules 300mg Gemfibrozil 300mg Medochemic Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1544 BRU14121674P Milosec Capsule 20mg Omeprazole 20mg The United Drug (1966) Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1545 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
1546 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
1547 BRU14121677P Pataday Olopatadine Ophthalmic
Solution 0.2%
Olopatadine hydrochloride 2.22mg (eq. to
Olopatadine 2mg (0.2%)
Alcon Laboratories, Inc., USA Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1548 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
1550 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
1551 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
1552 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
1553 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
1557 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
(1000's)
1558 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
BDMCA/RMP/1116 Page 92 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1559 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
Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1561 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
1562 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
benzalkonium chloride 0.198% Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1566 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
1567 BRU14121699P Invokana 300mg FCT Canagliflozin 300mg (as hemihydrate) Janssen Ortho, LLC, Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1568 BRU14121700P Amlodipine Tablet 10mg Amlodipine Tablet 10mg Jubilant Generics, Limited, India Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1569 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
Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1580 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
1581 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
1582 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
1583 BRU15011715P Ospamox 250mg Capsule Amoxicillin 250mg (as trihydrate 287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1584 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
Mesalazine 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1586 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
1587 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
1588 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
1589 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
1590 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
1591 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
1592 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 2015 till 18 May
2020
POM
1593 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
1594 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
1595 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
BDMCA/RMP/1116 Page 94 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1596 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
1597 BRU15011729P Nootropil Solution 20% Piracetam 20g/100ml NextPharma SAS., France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1598 BRU15011730P Bridion Solution for Injection
100mg/ml
Sugammadex 100mg/ml N.V. Organon, The Netherlands; Organon
(Ireland) Ltd., Ireland; Patheon
Manufacturing Services LLC, USA
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1599 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1624 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
1625 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
1626 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1639 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
1640 BRU15021772P Presolin 150 tablet Irbesartan 150mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1641 BRU15021773P Presolin 300 tablet Irbesartan 300mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1642 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
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1664 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
1665 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
1666 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
BDMCA/RMP/1116 Page 99 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1667 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
1668 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
1669 BRU15021801NP Calactate 300mg tab Calcium Lactate pentahydrate 300mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
1702 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
1703 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
1704 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
1705 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
1706 BRU15041838P Rocephin for Injection 250mg IM Ceftriaxone sodium (eq. to ceftriaxone
250mg/vial)
F.Hoffman-La Roche Ltd., France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1707 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
1708 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
1709 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM
1740 BRU15051872P Diamitex Tablet 80mg Gliclazide 80mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM
1741 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
1742 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
BDMCA/RMP/1116 Page 104 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1743 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
1744 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
1745 BRU15051877P Progyluton Tablet Estradiol Valerate (in brown tablet) 2mg;
Estradiol Valerate (in white tablet) 2mg;
Norgestrel (in brown tablet) 0.5mg
Bayer Weimar GmbH und Co. KG.,
Germany
Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1746 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)
1747 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 POM
1748 BRU15052038P 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
1749 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
1750 BRU15061881P Norditrophin Nordilet Inejction
5mg/1.5ml Pre-filled Pen,
Solution for Injection
Somatropin (rDNA) 3.3mg/ml Nove Nordisk A/A, Denmark Medipharm Sdn Bhd 28 July 2015 till 27 July 2020 POM
1751 BRU15061882P Aceprin 10mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM
G & H Trading Company 28 July 2015 till 27 July 2020 POM
1755 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
1756 BRU15061887P 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
Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1759 BRU15061890P Azoren 40mg/10mg Film-Coated
Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as amlodipine
besylate) 10mg
Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1760 BRU15061891P Azoren 40mg/5mg Film-Coated
Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as amlodipine
besylate) 5mg
Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
BDMCA/RMP/1116 Page 105 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1761 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
1762 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
Hamitan Marketing 28 July 2015 till 27 July 2020 GSL
1765 BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn. Bhd. 28 July 2015 till 27 July 2020 GSL
Reckitt Benckiser Healthcare (UK) Ltd, UK Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1770 BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd, Taiwan G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1771 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
1772 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
Heparin sodium 5000IU/ml Duopharma (M) Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1786 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
1787 BRU15081918P Olanzapine Orodispersible
Tablets 5mg
Olanzapine 5mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1788 BRU15081919P Olanzapine Orodispersible
Tablets 10mg
Olanzapine 10mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1791 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
1792 BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1793 BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1794 BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1796 BRU15091927P Axcel Piroxicam-10 Capsule Piroxicam 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1797 BRU15091928P Acular Ophthalmic Solution 0.5% Ketorolac Trometamol 0.50% w/v Allergan Pharmaceuticals Ireland, Ireland MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1798 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1799 BRU15091930P Zymar® (gatifloxacin opthalmic
solution) 0.3%
Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
BDMCA/RMP/1116 Page 107 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1800 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
1801 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
1802 BRU15091933P Gadovist Injection 1.0mmol/ml 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
1803 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
K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1806 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
1807 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
1808 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
1809 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
1810 BRU15091941P Irprestan Tablet 150mg Irbesartan 150mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1811 BRU15091942P Irprestan Tablet 300mg Irbesartan 300mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1815 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
1816 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 POM
BDMCA/RMP/1116 Page 108 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1817 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
1818 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
1819 BRU15101950P Respidon 2mg Tablets Risperidone 2mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1820 BRU15101951P Respidon 1mg Tablets Risperidone 1mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1822 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
1823 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
Biocon Limited, India Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1829 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
1830 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
1831 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
1832 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
Benzocaine 20% Dental Technologies Inc. , United States L S Kai Care 09 Dec 2015 till 16 Feb 2018 POM
1839 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
1840 BRU15111971PT SOLIRIS Concentrate for Solution
for Infusion 300mg
Eculizumab 300mg DSM Pharmaceuticals Inc, USA Medipharm Sdn Bhd 09 Dec 2015 till 23/11/2018 POM
1841 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
1842 BRU15121973P SW-Dexasone Tablet Dexamethasone 0.5mg Sunward Pharmaceutical Sdn Bhd.,
Singapore
G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1843 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
1844 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
1845 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
1846 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
1847 BRU15121978P Axcel Clomiphene Tablet Clomiphene Citrate 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1848 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
1849 BRU15121980NP Dexxon Lozenges Dequalinium Chloride 0.25mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1851 BRU16011982NP 0.9% Sodium Chloride Solution,
USP
Sodium Chloride USP 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
BDMCA/RMP/1116 Page 110 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1852 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
1853 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
1854 BRU16011985P Azukon MR 30mg Tablet Gliclazide 30mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1855 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
1856 BRU16011987P Zenalb 20% Human albumin 20%w/v Bio Product Lab, UK Medipharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1857 BRU16011988P Lestric Tablets 20mg Lovastatin 20mg Ranbaxy (Malaysia) Sdn Bhd., Malaysia G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
Belimed SA, Spain Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1860 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
1861 BRU16011992P Pharmaniaga Gliclazide Tablet
80mg
Gliclazide 80mg Pharmaniaga Manufacturing Berhad,
Malaysia
G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1862 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
1863 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
1864 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
1865 BRU16011996NP Coxan Tablets 500mg Paracetamol 500mg Prime Pharmaceuticals Sdn Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1866 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
1867 BRU1602070P 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
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
Biocon Limited, India Hongkiat Trading & Co 21 Jun 2016 till 20 Jun 2021 POM
1869 BRU16021999P Levetiracetam tablet 500mg Levetiracetam 500mg Jubilant Generics, Limited, India Axterix United (B) Sdn. Bhd 21 Jun 2016 till 20 Jun 2021 POM
1870 BRU16022000P Glimicron 80mg tablet Gliclazide 80mg HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 POM
BDMCA/RMP/1116 Page 111 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1871 BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 GSL
1872 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
1873 BRU16022003P Mircera pre-filled syringe
100mcg/0.3ml
Methoxy polyethylene glycol-epoetin beta
100mcg/0.3ml
Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1874 BRU16022004P Glucodex tablet Gliclazide 80mg PT Dexa Medica, Indonesia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
Torrent Pharmaceuticals Limited, India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1883 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
1884 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
1885 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
Biocon Limited, India Hongkiat Trading & Co. 21 Jun 2016 till 20 Jun 2021 POM
1887 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
BDMCA/RMP/1116 Page 112 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1888 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
1889 BRU16032019P Levetiracetam 250mg tablet Levetiracetam 250mg Jubilant Generics Limited, India Asterix United (B)Sdn Bhd., 21 Jun 2016 till 20 Jun 2021 POM
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL
1894 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
1895 BRU16042025P Romesec 20mg Capsules Omeprazole USP 20mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia. G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1907 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
1908 BRU16052039NP Noxworm Chewtab Albendazole 200mg Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1909 BRU16052040P 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
1910 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
1911 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
1912 BRU16052043P Axcel Dextromethorphan-15
Syrup
Dextromethorphan hydrobromide
15mg/5ml
Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1913 BRU16052044P Zometa Solution for Infusion
4mg/100ml
Zoledronic Acid (anhydrous) 4mg/100ml
corresponding to 4.264mg Zoledronic Acid
Monohydrate
Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1926 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
1927 BRU16072058P Noxafl 100mg tablet Posaconazole 100mg N.V Organon, Netherlan Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07