34TH BDMCA MEETING 1 LAMPIRAN C AGENDA 4.3 - APPROVED … Documents/Traditional Medicines... · 2020. 7. 27. · 34TH BDMCA MEETING 1 LAMPIRAN C No Application Variation Ref. No.

34TH BDMCA MEETING 1 LAMPIRAN C

No Application Variation Ref. No. Product Name Active ingredientsProduct

Registration No.Variations Company

1 (575)/DRU/DRA.Variation/2017Eprex® 2000 Prefilled

Syringe 2000IU/0.5mlEpoetin alfa 2, 000IU/0.5ml BRU12110959P

1 - Minor (MiV-PA) - Update of

information in various section of

dossier

Zuellig Pharma (B) Sdn Bhd


Syringe 4000IU/0.4mlEpoetin alfa 4, 000IU/0.4ml BRU12110955P



dossier



Syringe 10,000U/1mlEpoetin alfa 10,000 IU/ml BRU14091494P



dossier


4 (578)/DRU/DRA.Variation/2017Eprex® 40,000 Prefilled

Syringes 40,000iu/mlEpoetin alfa 40,000 IU/ml BRU14121673P



dossier


5 (748)/DRU/DRA.Variation/2018 Xeloda Tablet 150mg Capecatibine 150mg BRU13061084P

1 - Major (MaV-4) - Addition of

manufacturing, quality control and

microbiological testing site of drug

product

2 - Minor (MiV-PA2) - Change in outer

carton label and package insert

(Version: TAB-XEL-2017 02-0, Date of

revision ; Mar 2017)

3 - Minor (MiV-PA5) and MiV-PA6 -

Change in-process control applied

during the manufacture of drug

substance and change in batch size of

the drug substance

4 - Minor (MiV-PA19) - Change of in-

process controls applied during the

manufacture of the drug product.

Hongkiat Trading &

Company

AGENDA 4.3 - APPROVED VARIATIONS DURING THE 145, 146 & 147TH DRC MEETING

"The following applications for variations have been evaluated and were found to be satisfactory, and recommended by the Drug Registration Committee for endorsement by the BDMCA for approval of

variation as stated below"

145th DRC Variations (158 applications)


6 (749)/DRU/DRA.Variation/2018 Xeloda™ Tablets 500mg Capecatibine 500mgBRU13061076P;

BRU13061076PS2

1 - Major (MaV-4) - Addition of

manufacturing, quality control and

microbiological testing site of drug

product

2 - Minor (MiV-PA2) - Change in outer


(Version: TAB-XEL-2017 02-0, Date of

revision ; Mar 2017)

3 - Minor (MiV-PA5) and MiV-PA6 -

Change in-process control applied

during the manufacture of drug

substance and change in batch size of

the drug substance

4 - Minot (MiV-PA19) - Change of in-


manufacture of the drug product

Hongkiat Trading &

Company

7 (831)/DRU/DRA.Variation/2018Tagrisso 40mg Film-

coated tabletsOsimertinib 40mg BRU18082390P

1 - Major (MaV-1) including Minor

(MiV-PA2) - Addition of indication

extending the usage of the product and

change of package insert (Doc ID-

003170737, Version 5.0, Date of

revision: November 2018)


8 (832)/DRU/DRA.Variation/2018Tagrisso 80mg Film-

coated tabletsOsimertinib 80mg BRU18082391P


(MiV-PA2) - Addition of indication

extending the usage of the product and

change of package insert (Doc ID-

003170737, Version 5.0, Date of

revision: November 2018)


9 (865)/DRU/DRA.Variation/2018Cytarabine® Injection

1000mg/10mlCytarabine 1000mg/10ml BRU10040461P

1 - Major (MaV) - Revision of Drug

Master File (DMF)

2 - Major (MaV-6) - Change of

specification and test methods of drug

substance [Where European

Pharmacopoeial Certifcate of

Suitability (CEP) is not available]

3 - Minor (MiV-PA1) - Change in name

of drug product

4 - Minor (MiV-PA2) - Change of inner

label, outer carton label and package

insert (Version : CYTRARABINE-0118,

Date of revision : 15 Jan 2018)

5 - Minor (MiV-N7) - Deletion of

laternative manufacturer



10 (990)/DRU/DRA.Variation/2018Eylea Solution for

Injection (vial)Aflibercept 40mg/ml BRU14111544P


(MiV-PA8) - Change of the specification

of drug substance and drug substance

intermediate

2 - Minor (MiV-PA9) - Change in the

test procedure of the drug substance

3 - Minor (MiV-PA27) - Change in test

procedure of drug product

4 - Minor (MiV-PA) - Minor change in

manufacturing process of drug

substance

5 - Minor (MiV-PA) - Change in

specification parameters and/or limits

of a raw material

6 - Minor (MiV-PA) - Addition of

available stability data regarding the

Working Cell Bank

7 - Minor (MiV-PA) - Deletion of quality

control and warehouse site (Vetter

site) for finished product


alternative QC site

9 - Minor (MiV-PA) - Change in test

procedure of in-process control

parameter of drug product

10 - Minor (MiV-PA) - Editorial

amendment of container closure

system



11 (991)/DRU/DRA.Variation/2018

Eylea Solution for

Injection (pre-filled

syringe)

Aflibercept 40mg/ml BRU14111545P


(MiV-PA8) - Change of the specification

of drug substance and drug substance

intermediate


test procedure of the drug substance

3 - Minor (MiV-PA27) - Change in test

procedure of drug product

4 - Minor (MiV-PA) - Minor change in


substance


specification parameters and/or limits

of a raw material


available stability data regarding the

Working Cell Bank

7 - Minor (MiV-PA) - Deletion of quality

control and warehouse site (Vetter

site) for finished product


alternative QC site

9 - Minor (MiV-PA) - Change in test

procedure of in-process control

parameter of drug product



Perjeta Concentrate for

Solution for Infusion

420mg/14ml

Pertuzumab 420mg BRU18022312P

1 - Major including (MaV-1) including

Minor (MiV-PA2) - Update in indication

including change in package insert

(Version : INF-PER-2018 12, Date of

revision: December 2018)

2 - Minor (MiV-PA9) - Change of the

test procedure of non-compendial drug

substance

3 - Minor (MiV-PA) - Addition of system

suitability criteria

Medipharm Sdn Bhd

13 (42)/DRU/DRA.Variation/2019 Lioresal 10mg Tablet Baclofen 10mg BRU10080533P




2 - Minor (MiV-PA20) - Minor change

of the manufacturing process for non-

sterile product

3 - Minor (MiV-PA) - Update of P1

Description and Composition of drug

product

4 - Minor (MiV-PA) - Change in batch

formula



14 (48)/DRU/DRA.Variation/2019 Pentaxim Vaccine

Composition of final

container per dose (0.5ml):

TETRAXIM - Purified diptheria

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

BRU11080747PS1,

BRU11080747PS2,

BRU11080747PS3

1 - Minor (MiV-PA) - including MiV-PA2

- Update in description and

composition of active substance and

excipients list including change in outer

carton and package insert (Version :

MYPentaximxx19/SPC0518)


description of Container Closure

System presentation


15 (53)/DRU/DRA.Variation/2019Erbitux® 5mg/ml Solution

for InfusionCetuximab 5mg/ml BRU13091130P

1 - Minor (MiV-PA2) - Change of

package insert (Date of information :

September 2018 CCDS V16)

2 - Minor (MiV-P5) - Change of batch

size of drug substance (where

European Pharmacopoeial Certificate

of Suitability (CEP) is not available]


specification of drug substance


16 (59)/DRU/DRA.Variation/2019 Alphanate 250IU

Factor VII 250IU and von

Willebrand Factor

>400IU/1000IU Factor VII

BRU16082066NP

1 - MiV-PA24 - Change of release and

shelf-life specifications of the drug

product

2 - MiV-PA27 - Change in the test

procedure of the drug product

(including replacement or addition of a

test procedure)



Nimenrix™

(Meningococcal

polysaccharide

serogroups A,C,W-135, Y)

Vaccine

MenAAH-TT-conjugate (Mean

TT/PS ratio:3) 5mcg PSA-

15mcg TT, MenCAH-TT-

conjugate (Mean TT/PS

ratio:3) 5 mcg PSC-15mcg TT,

MenW-TT-conjugate (Mean

TT/PS ratio:1.5) 5mcg PSW-

7.5mcg TT, MenY-TT-

conjugate (mean TT/PS ratio:

1.3) 5mcg PSY-6.5mcgTT

BRU15031814P

1 - Major (MaV-15) - Extension of shelf-

life of the drug product

2 - Minor (MiV-PA) - Addition of a

mixing step to MenAAH -TT durg

subtsance before start of formulation



18 (121)/DRU/DRA.Variation/2019Nitroderm TTS 5

(5mg/24hr)

Glyceryl

Trinitrate/Nitroglycerin 25mgBRU10020418P

1 - MaV-4 - Addiiton of manufacturing

site of drug product

2 - MiV-PA19 - Addition and

replacement of In-process Controls

(IPC) test parameters

3 - MiV-PA24 - Change in the testing

monograph of the finished product


19 (122)/DRU/DRA.Variation/2019 Nitroderm TTS 10

Glyceryl

Trinitrate/Nitroglycerin 50mg

(10mg/24hr)

BRU10040452P

1 - MaV-4 - Addiiton of manufacturing

site of drug product

2 - MiV-PA19 - Addition and

replacement of In-process Controls

(IPC) test parameters

3 - MiV-PA24 - Change in the testing

monograph of the finished product


20 (136)/DRU/DRA.Variation/2019 Omesec Capsule 20mg Omeprazole 20mg BRU10030427P

1 - MiV-PA2 - Change of product

labelling (inner label, outer carton and

package insert, new date of revision

05.12.-17 SAP code 1500007271 V.5)

K-Seri Pharma Sdn BHd

21 (141)/DRU/DRA.Variation/2019Myfortic Gastro-Resistant

tablet 180mg

Mycophenolic Acid 180mg (as

Sodium Salt 192.4mg)BRU10060505P

1 - Minor (MiV-PA2) - Change of outer

carton lable


manufacturing process of the drug

substance (where European

Pharmacopoeial Cetificate of Suitability

(CEP) is not available)


specification of an excipient

4 - Minor (MiV-PA) - Update of drug

product stability data


22 (142)/DRU/DRA.Variation/2019Myfortic Gastro-Resistant

tablet 360mg

Mycophenolic (as sodium)

acid 360mgBRU10100556P


carton lable


manufacturing process of the drug

substance (where European

Pharmacopoeial Cetificate of Suitability

(CEP) is not available)


specification of an excipient

4 - Minor (MiV-PA) - Update of drug

product stability data


23 (144)/DRU/DRA.Variation/2019Sandimmun Neoral

Capsule 100mgCiclosporin 100mg BRU13101156P

1 - MiV-PA13 - Change of batch size of

non-sterile drug product

2 - MiV-PA21 - Change of specification

of an excipient

3 - MiV-PA22 - Change of a test

procedure for an excipient



24 (145)/DRU/DRA.Variation/2019Sandimmun Neoral

Capsule 25mgCiclosporin A 25mg BRU13071114P

1 - MiV-PA13 - Change of batch size of

non-sterile drug product

2 - MiV-PA21 - Change of specification

of an excipient

3 - MiV-PA22 - Change of a test

procedure for an excipient


25 (149)/DRU/DRA.Variation/2019 Noriday Tablet Norethisterone 0.35mg BRU13061080P


labelling )inner label, outer carton and

package insert, new date of revision 30

September 2019 version NORIDAY-M-

0919)



Zarzio 30 MU/0.5ml

Solution for Injection or

Infusion in Pre-filled

Syringe

30 million units (equivalent to

300mcg) filgrastim in 0.5mlBRU18042344P


carton label and package insert (date

of revision : 11 July 2018)

2 - Minor (MiV-PA3) - Replacement of

the company or party responsible for

batch release


27 (202)/DRU/DRA.Variation/2019Suprane Inhalation Liquid

100%Desflurane 100% BRU14091477P

1 - MiV-PA9 - Change of the test

procedure of non-compendial drug

substance



3 - MiV-PA28 - Change of the container

closure system


28 (204)/DRU/DRA.Variation/2019 Retrovir 1% IV Infusion Zidovudine 1% BRU08030031P

1 - Minor (MiV-PA2) - Change in inner


insert (Version: v01, Reference:

VGDS36/IPI09, Date of revision : 22

June 2018)

2 - Minor (MiV-PA20) - Minor change

of the manufacturing process of drug

product


test procedure of drug product


release and shelf-life specification of

drug priduct

5 - Minor (MiV-N6) - Change of address

of a manufacturer of the drug

substance

6 - Minor (MiV-N9) - Change of release

and shelf-life specifications of drug

substance following the updates in

compendium



29 (205)/DRU/DRA.Variation/2019Beconase Aqueous Nasal

Spray

Beclomethasone

Dipropionate (as

monohydrate)

BRU10110596P

1 - MiV-PA35 - Change of storage

conditions of the drug product

(increasing from the current approved

storage condition)



package insert, new revision date 18

July 2018; Beconase V02; GDS18/IPI06)


30 (212)/DRU/DRA.Variation/2019Xarelto Film-coated

tablet 10mgRivaroxaban 10mg BRU12090933P

1 - MiV-PA others - Addiiton of

alternative site for stablity storage and

testing

2 - MiV-PA7 - Change of manufacturing

process of the drug substance (where

CEP is not available)






testing









testing





33 (231)/DRU/DRA.Variation/2019Prevenar 13 Suspension

for Injection

Per 0.5ml - Pneumococcal

Polysaccharide Serotype

1,3,4,5, 6A, 7F, (V, 14, 18C,

19A, 19F, 23F -

2.2mcg;Pneumococcal

Polysaccharide Serotype 6B-

4.4mcg

BRU13021008P

1 - MiV-PA3 and MiV-PA29 - Change of

the company or party responsible for

batch release and secondary packaging

site


labelling (outer label and inner label)


34 (233)/DRU/DRA.Variation/2019Gaviscon Double Action

Liquid

Per 10ml - Sodium Alginate

500mg; Sodium Bocarbonate

213mg; Calcium Carbonate

325mg

BRU15071906NP

1 - MiV-PA19 - Change of in-process

controls applied during manufacture of

drug product

2 - MiV-PA20 - Minor changes of

manufcaturing process for drug

product

Syarikat Aliaa Sdn Bhd


35 (242)/DRU/DRA.Variation/2019 Panaflex Pain Relief Patch

Glycol Salicylate 1.5% w/w, L-

Menthol 1.0% w/w, DL-

Camphor 0.5%w/w, DL-A-

Tocopherol Acetate 0.3% w/w

BRU12030872NP

1 - MiV-PA15 - Qualitative and

quantitative change of excipient for

other non-critical dosage forms eg.

Oral liquid, external preparation

2 - MiV-PA20 - Minor changes of

manufcaturing process for non-sterile

product

3 - MiV-PA19 - Change of in-process

controls applied during the


(inlcuding tightening and addition of

new in-process test)

Kingston Beverage &

Creamery Sdn Bhd

36 (243)/DRU/DRA.Variation/2019 Panaflex Pain Relief Patch





BRU12030872NP


labelling (inner label and outer carton)

2 - MiV-PA31 - Change of outer carton

pack sizes for a drug product

Kingston Beverage &

Creamery Sdn Bhd

37 (244)/DRU/DRA.Variation/2019Panaflex ® Pain Relief

Patch





BRU12030872NP

1 - MaV-6 - Change of the specification

of drug product where CEP is not

available



(including replacement or addition of a

test procedure)

Kingston Beverage &

Creamery Sdn Bhd

38 (247)/DRU/DRA.Variation/2019Cordarone Injection

150mg/3mlAmiodarone 150mg/3ml BRU09030216P

1 - MiV-PA8 - Change of the


2 - MiV-PA9 - Change oh the test


substance

Medipharm Sdn Bhd

39 (248)/DRU/DRA.Variation/2019 Cordarone Tablet 200mg Amiodarone HCI 200mg BRU08110162P



substance

Medipharm Sdn Bhd

40 (252)/DRU/DRA.Variation/2019Hyzaar Forte Tablet

100/25mg

Losartan potassium 100mg,

Hydrochlorothiazide 25mgBRU11030671P


labelling (package insert, new revision

date February 2019 SG-MK0954A-T-

022019)


41 (253)/DRU/DRA.Variation/2019Hyzaar® Tablet

50/12.5mg

Losartan Potassium 50mg,

Hydrochlorothiazide 12.5mgBRU11090768P




022019)


42 (254)/DRU/DRA.Variation/2019Hyzaar® Plus Tablet

100/12.5mg

Losartan Potassium 100mg,

Hydrochlorothiazide 12.5mgBRU11090769P




022019)




Clexane 2000 anti-Xa

IU/0.2ml (Pre-filled

Syringe for Injection)

Enoxaparin Sodium 2,000 anti-

Xa IU/0.2mlBRU13101153P




Medipharm Sdn Bhd

44 (257)/DRU/DRA.Variation/2019Clexane 4000/0.4ml Anti

Xa Pre-filled Syringe


Xa IU/0.4ml equivalent to

40mg/0.4ml

BRU13091133P




Medipharm Sdn Bhd

45 (258)/DRU/DRA.Variation/2019Clexane 6000/0.6ml Anti-

Xa IU Pre-filled Syringe


Xa IU/0.6ml equivalent to

60mg/0.6ml

BRU13091138P




Medipharm Sdn Bhd

46 (259)/DRU/DRA.Variation/2019 Xatral XL Tablet 10mg Alfuzosin HCI 10mg BRU10020421P


labelling; package insert new revision

date Sept 2018 CCDS V12 - France

SmPC Oct 17

Medipharm Sdn Bhd

47 (280)/DRU/DRA.Variation/2019Menveo Powder &

Solution for injection

One dose (0.5ml of the

reconstituted vaccine)

contains:

Originally contained in the

powder: meninggococcal

group A oligosaccharide

10micrograms

(conjugated to

Corynebacterium diptheria

CRM197 protein 16.7 to 33.3

micrograms)


solution: Meninggococcal

group C oligosaccharide

5micrograms

(Conjugated to

Corynebcaterium diptheria

CRM197 protein...7.1 to 12.5

micrograms); Meninggococcal

group W135 oligosaccharide

5micrograms (conjugated to

Corynebacterium diptheriaa



group Y oligosaccharide

5micrograms (Conjugated to


CRM197 protein..5.6 to 10.0

micrograms)

BRU14031269P


label, inner label and package insert

(version number: 01, Reference : EU

SPC 24 Jan 2019, date of local revision :

28 March 2019)


48 (300)/DRU/DRA.Variation/2019 Zinnat Tablet 250mg Cefuroxime (as axetil) BRU08030037P


release and shelf-life specifications of

the drug product.



49 (309)/DRU/DRA.Variation/2019Azopt Eye Drops,

Suspension

Brinzolamide 10mg/ml (1.0%

w/w)BRU13021015P


product labelling (package insert, new

revision date February 2018 TDOC-

0017242 Version 2.0)


50 (310)/DRU/DRA.Variation/2019Maxidex Sterile

Opthalmic Suspension

Dexamethasone 0.1%

(1mg/ml)BRU14071360P



date March 2018 TDOC-0051104

Version: 2.0)


51 (314)/DRU/DRA.Variation/2019 Cataflam 50 Tablet Diclofenac Potassium 50mg BRU09090318P1 - MiV-PA28 - Change in immediate

packaging material of finished productZuellig Pharma (B) Sdn Bhd


Strepsils Strawberry

Sugar Free Children

Lozenge

Amylmetacresol 0.6mg; 2.4 -

Dichlorobenzyl Alcohol 1.2mgBRU14121681NP

1 - MiV-PA4 - Change of manufacturer

of drug substance (where CEP is

available)

Syarikat Aliaa Sdn Bhd

53 (318)/DRU/DRA.Variation/2019Orgalutron Solution for

Injection 0.25mg/0.5ml

Ganirelix acetae

0.25mg/0.5mlBRU10120602P

1 - MiV-PA (Others) - To add

alternative drug substance testing site

& update the registration dossier


54 (331)/DRU/DRA.Variation/2019Trileptal Film-coated

Tablets 300mgOxcarbazepine 300mg BRU14111558P

1 - MaV-3 - Update on the drug

substance manufacturers and QC sites

2 - MiV-PA7 - Update on the


substance where CEP is not available

3 - MiV-PA (Others) - Update on the

specification for raw material


55 (332)/DRU/DRA.Variation/2019Trileptal 600mg Film-

coated TabletsOxcarbazepine 600mg BRU14091490P

1 - MaV-3 - Update on the drug

substance manufacturers and QC sites

2 - MiV-PA7 - Update on the


substance where CEP is not available

3 - MiV-PA (Others) - Update on the

specification for raw material


56 (333)/DRU/DRA.Variation/2019 Comtan® Tablet 200mg Entacapone 200mg BRU11010632P1 - MiV-PA others - Update on the drug

substance QC sitesZuellig Pharma (B) Sdn Bhd

57 (334)/DRU/DRA.Variation/2019Stalevo 50/12.5/200mg

film-coated tablet

Levodopa 50mg, Carbidopa

12.5mg, Entacapone 200mgBRU11080746P

1 - MiV-PA others - Addition of quality

control siteZuellig Pharma (B) Sdn Bhd

58 (335)/DRU/DRA.Variation/2019Stalevo 100/25/200mg

Film-coated tablet

Levodopa 100mg; Carbidopa

25mg; Entacapone 200mgBRU11040694P




Film-coated Tablet


37.5mg; Entacapone 200mgBRU11100786P





Film-coated tablet


18.75mg; Entacapone 200mgBRU14031251P



61 (338)/DRU/DRA.Variation/2019Stalevo 200/50/200mg

film-coated tablet


50mg; Entacapone 200mgBRU14031252P




Stalevo

125/31.25/200mg film-

coated tablet

Levodopa 125mg, Carbidopa

31.25mg, Entacapone 200mgBRU14091517P



63 (340)/DRU/DRA.Variation/2019Talgesil injection

0.1mg/2ml (amp)Fentanyl 0.1mg/2ml BRU18022319P




labelling (outer carton and package

insert)

3 - MiV-N9 - Change of release and

shelf-life specifications of the drug

product, following the updates in the

compendium



Diprivan 10mg/ml (1%)

Emulsion for Injection or

Infusion (20ml Ampoule)

Propofol 10mg/ml (1%) BRU08020020P



package insert new date of revision 15

October 2018 CCDS May

2017/01/1018)


65 (342)/DRU/DRA.Variation/2019Duratocin 100mcg/ml

InjectionCarbetocin 100mcg/ml BRU18122486P

1 - MaV-13 - Change of container

closure system of a sterile liquid drug

product


66 (343)/DRU/DRA.Variation/2019Keppra 250mg Film-

coated TabletLevetiracetam 250mg BRU13061081P


package insert (Version: v05,

Reference: NCDS09, Date of Revision :

30 November 2018)


67 (344)/DRU/DRA.Variation/2019Keppra 500mg Film-

coated TabletLevetiracetam 500mg BRU13061082P




30 November 2018)


68 (345)/DRU/DRA.Variation/2019Keppra® Oral Solution

100mg/mlLevetiracetam 10mg/ml BRU15061880P




30 November 2018)


69 (346)/DRU/DRA.Variation/2019Endoxan Injection

200mg/vial

Cyclophosphamide

monohydrate 213.8mg (eq.

To anhydrous

Cyclophosphamide 200mg)

BRU14041293P1 - MiV-PA2 - Change of product

labelling (inner label and outer carton)Zuellig Pharma (B) Sdn Bhd

70 (347)/DRU/DRA.Variation/2019 Omezole 20mg capsule Omeprazole 20mg BRU15041841P



insert, new revision date June 2017

VIOME01-3)

G&H Trading Company


71 (349)/DRU/DRA.Variation/2019 Benzhexol Tablet 2mg Benzhexol HCI 2mg BRU11050702P


labelling (outer carton version T611A-

R6, and package insert version TL611A-

R2)

G&H Trading Company

72 (350)/DRU/DRA.Variation/2019Calcium Lactate Tablet

300mgCalcium Lactate 300mg BRU18102421NP

1 - MiV-PA1 - Change of drug product

name with consequential version of

label (inner label and package insert

version TL615A-R11; revision date:

24/05/2018)



G&H Trading Company

73 (351)/DRU/DRA.Variation/2019Hydrocortisone Cream

1% w/w

Hydrocortisone acetate 1%

w/wBRU09070282P

1 - MiV-PA1 - Change of drug product

name


conditions of the drug product,


labelling (inner label & package insert

new revision date 28/04/2017, EL210A-

R11)

G&H Trading Company

74 (352)/DRU/DRA.Variation/2019Metoclopramide Syrup

5mg/5ml

Metoclopramide

hydrochloride 5mg/5mlBRU10110587P

1 - MaV-1 - Change and/or additional

indication/dosing regimen/patient

population/inclusion of clinical

information extending the usage of the

product

2 - MaV-4 - Addition of the

manufacturing site of the drug product

3 - MiV-PA2 - Addition of product

labelling (inner label & package insert,

CL317A-R8 revised on 22 February

2019) for source country, Malaysia

4 - MiV-PA30 - Addition of pack size/fill

volume and/or change of shape or

dimension of container or closure for

non-sterile product



G&H Trading Company

75 (355)/DRU/DRA.Variation/2019 Tegretol 2% Syrup Carbamazepine 100mg/5ml BRU11020647P

1 - MiV-PA28 - Revision of the

specification of primary packaging

material for non-sterile product

2 - MiV-PA21 - Change of specifications

of non pharmacopoeial excipient to

pharmacopoeial specifications




Advate 250 IU Powder

and Solvent for Solution

for Injection

Octocog alfa (recombinant

human coagulation factor

VIII) 250 IU

BRU14111595P1 - Change of product labelling (outer

carton and inner vial labels)Zuellig Pharma (B) Sdn Bhd


Advate 500 IU Powder

and Solvent for Solution

for Injection

Octocog alfa (recombinant

human coagulation factor

VIII)

BRU15031823P1 - Change of product labelling (outer

carton and inner vial labels)Zuellig Pharma (B) Sdn Bhd

78 (362)/DRU/DRA.Variation/2019Crinone Progesterone

Vaginal Gel 8%Progesterone 8% BRU14091486P

1 - MiV-PA4 - Addition of alternative

manufacturer of drug substance where

CEP is available



substance



G&H Trading Company

79 (363)/DRU/DRA.Variation/2019Mucodin syrup

250mg/5mlCarbocysteine 250mg/5ml BRU15041843P

1 -MiV-PA30 - Addition of pack size of

drug productG&H Trading Company

80 (364)/DRU/DRA.Variation/2019 Sunadine Syrup Loratadine 5mg/5ml BRU10020414P

1 -MiV-PA2 - Change of product

labelling (package insert, new revised

code : CL673A-R7, date : 07/08/2018)

G&H Trading Company

81 (365)/DRU/DRA.Variation/2019 Sunadine tablet 10mg Loratadine 10mg BRU15041847P


package insert (Version: CL673A-R7,

Date or revision: 07/08/2018)

G&H Trading Company

82 (366)/DRU/DRA.Variation/2019 Zoloft Tablet 50mgSertraline (as hydrochloride)

50mgBRU09100337P


package insert (Version: ZOLOFT-1119,

Date of revision: 07 Nov 2019)


83 (367)/DRU/DRA.Variation/2019Coversyl Film-coated

Tablet 5mg

Perindopril arginine 5mg (eqv.

Perindopril 3.395mg)BRU11100788P

1 - MiV-N Others - Update purity grade

of water in the manufacturing process

(editorial)




84 (368)/DRU/DRA.Variation/2019Coversyl Film coated

Tablet 10mg

Perindopril Film-coated Tablet

10mg (eqv. Perindopril

6.790mg)

BRU11040696P

1 - MiV-N Others - Update purity grade

of water in the manufacturing process

(editorial)




85 (369)/DRU/DRA.Variation/2019Coversyl Plus

10mg/2.5mg tablet

Perindopril arginine 10mg

(equiv. to 6.79mg

perindopril); Indapamide

2.5mg

BRU12070923P


package insert (Version:

Final_PI_BRU_Coversyl Plus

10mg_28.05.2018, Date of revision: 28

May 2018)


86 (370)/DRU/DRA.Variation/2019Coveram Tablets

5mg/5mg


(equiv. to 3.395mg

perindopril); Amlodipine 5mg

(as besilate 6.935mg)

BRU11050710P



Final_PI_BRU_Coveram_07.12.2018,

date of revision: 07 December 2018)




5mg/10mg


(equiv. to 3.395mg

perindopril) and amlodipine

10mg (as besilate 13.870mg)

BRU11070736P







10mg/5mg


(eqv. To Perindopril

6.790mg); Amlodipine 5mg


BRU11100787P







10mg/10mg


(eqv. To Perindopril

6.790mg); Amlodipine 10mg


BRU11100791P







Bupivacaine

Hydrochloride BP 0.5%

w/v injection

Bupivacaine hydrochloride BP

0.5% w/vBRU09040239P

1 - Major (MaV-1) including MiV-PA2 -

Change of indication of the product

and update in package insert (version:

BUPIVACAINE-1018, Date of Revision :

26 OCT 2018)

2 - Major (MaV-7) - Change of batch

size of sterile drug product


product name


label, outer label and carton label


91 (376)/DRU/DRA.Variation/2019 Baneocin Ointment

Bacitracin Zinc 250IU/1g;

Neomycin Sulphate 5000 IU

(5mg) / 1g

BRU15021755P

1 - MiV-PA3 - Replacement of the

company or party responsible for batch

release

2 - MiV-PA12 - Revision of European

Pharmacopoeial Certifcate of

Suitability (CEP) of drug substance ,

Bacitracin Zinc


92 (377)/DRU/DRA.Variation/2019Montelair 10mg film-

coated tablet

Montelukast (as Montelukast

Sodium) 10mgBRU15021796P

1 -Major (MaV-1) including Minor (MiV-

PA2) - Addition of patient population

extending the usage of the product

including change of outer carton label

and package insert (Version: VIMON07-

PC1(MY), Date of revision : November

2015)

G&H Trading Company

93 (378)/DRU/DRA.Variation/2019Targocid® Injection

200mg

Teicoplanin 200mg/3ml

(200mg/vial)BRU12010857P

1 - Major (MaV-2) - Change in package

insert (date of revision : May 2017,

References: UK SmPC (May 2016) CCDS

v2)

Medipharm Sdn Bhd

94 (379)/DRU/DRA.Variation/2019Eliquis Film-coated

Tablets 2.5mgApixaban 2.5mg BRU14111573P

1 - MiV-PA Others - Update on the drug

substance analytical procduresZuellig Pharma (B) Sdn Bhd


95 (380)/DRU/DRA.Variation/2019Eliquis 5mg Film-coated

TabletApixaban 5mg BRU14111592P

1 - MiV-PA Others - Update on the drug

substance analytical procduresZuellig Pharma (B) Sdn Bhd

96 (381)/DRU/DRA.Variation/2019 Diovan 80mg Tablet Valsartan 80mg BRU10010391PS2

1 - Minor (MiV-PA2) - Change in

package insert (Date of revision : Sep

2018)


97 (382)/DRU/DRA.Variation/2019 Diovan® 160mg tablet Valsartan 160mg BRU10020409PS2


package insert (Date of revision : Sep

2018)


98 (383)/DRU/DRA.Variation/2019Ultravist 300 Injection

300mg/Ml

1ml contains 623mg

iopromide (equivalent to

300mg iodine)

BRU18092406P



insert (Version: : Ultravist PI_SG_CCDS

13_03 Apr 2019, date of Revision : 03

Apr 2019)

2 - Minor (MiV-N2) - Change of product

owner

3 - Minor (MiV-N4) including (MiV-N5) -

Change of the name of the

manufacturer of drug product

including change of the name of

manufacturer responsible for batch

release

4 - Minor (MiV-N6) - change of the

name of a manufacturer of the drug

substance


99 (384)/DRU/DRA.Variation/2019Ultravist 370 Injection

370mgUltravist/Ml

1ml contains769mg

iopromide (equivalent to

370mg iodine)

BRU18092407P



insert (Version: : Ultravist PI_SG_CCDS

13_03 Apr 2019, date of Revision : 03

Apr 2019)

2 - Minor (MiV-N2) - Change of product

owner

3 - Minor (MiV-N4) including (MiV-N5) -

Change of the name of the

manufacturer of drug product

including change of the name of

manufacturer responsible for batch

release

4 - Minor (MiV-N6) - change of the

name of a mnaufacturer of the drug

substance



100 (385)/DRU/DRA.Variation/2019oxynorm Oral Solution

5mg/5ml

Each 5ml contains oxycodone

base 4.5mg as oxycodone

hydrochloride 5mg

BRU16122126P

1 - Major (MaV-8) - Change of Batch

size of Non-Sterile Drug product



insert (Date of revision: Oct 2017)


primary packaging materials for non-

sterile product



Flutiform 50microgram/5

microgram Per Actuation

Pressurised inhalation

Suspesnion

Each metered dose (ex-valve)

contains:

50mcg of fluticasone

propionate and 5mcg of

formeterol fumarate

dihydrate,

This is equivalent to a

delivered dose (ex-actuator)

of approximately 46 mcg of

fluticasone propionate

4.5mcg of formoterol

fumarate dihydrate

BRU18022305P



insert (Date of revision: September

2013)



Flutiform

125microgram/5



Suspesnion


contains:



formeterol fumarate

dihydrate,






fumarate dihydrate

BRU18022307P




2013)



Flutiform

250microgram/10



Suspesnion


contains:



formeterol fumarate

dihydrate,






fumarate dihydrate

BRU18022306P




2013)



104 (390)/DRU/DRA.Variation/2019 Cef-4 1G InjectionCeftazidime (as pentahydrate)

1gBRU17022164P



insert (Version: CEF-4-500-03-L-ENG-

BN-A0002)


105 (391)/DRU/DRA.Variation/2019 Cef-4® Injection 500mgCeftazidime (as pentahydrate)

500mgBRU13101159P



insert (Version: CEF-4-500-03-L-ENG-

BN-A0002)


106 (392)/DRU/DRA.Variation/2019 Gastografin Solution

1ml contains Sodium

amidotrizoate 0.1g and

Meglumine amidotrizoate

0.66g

BRU16011990P


package insert (Version: Gastrofin

CCDS 7_07.01.2019, Date of revision :

07-01.2019)



Curam 156.25mg/5ml

Powder for Oral

Suspension

Per 5ml - Amoxycillin 125mg

9as trihydrate) ; Clavulanic

acid 31.25mg

BRU14111615P


label, outer carton and package insert

(date of revision : July 2018 (CDS Feb

2014)


108 (394)/DRU/DRA.Variation/2019Curam Powder for oral

suspension 312.5mg/5ml

Amoxycillin 250mg (as

trihydrate); Clavulanic Acid

62.5mg (As potassium salt)

BRU14071384P



(date of revision : July 2018 (CDS Feb

2014)



Triplixam

2.5mg/0.625mg/5mg

Film-coated Tablets

Amoxycillin 250mg (as

trihydrPerindopril arginine

2.5mg (corresponding to

1.6975mg of perindopril)

Indapamide 0.625mg

Amlodipine besilate 6.935mg

(corresponding to 5mg of

amlodipine)

BRU17042184P

1 - Major (MaV-15) - Extension of the

shelf-life of the drug product



Proposed_PI_Brunei_Triplixam_18.12.

2018, Date of revision : 18 December

2018)



Triplixam

5mg/1.25mg/5mg Film-

coated Tablets


(corresponding to 3.395mg of

perindopril) Indapamide

1.25mg Amlodipine besilate


5mg of amlodipine)

BRU17042185P







2018)



Triplixam


coated Tablets






10mg of amlodipine)

BRU17042186P







2018)




Triplixam

10mg/2.5mg/5mg film-

coated tablets






5mg of amlodipine)

BRU17042187P







2018)



Triplixam


coated tablets






10mg of amlodipine)

BRU17042188P







2018)


114 (406)/DRU/DRA.Variation/2019 Voltaren® SR Tablet Diclofenac Sodium 75mg BRU09090317P


package insert (Version : 2017-PSB/GLC-

0907-s, Date of revision : 27 Nov 2018

2 - Minor (MiV-PA25) -Change of

imprints on the tablets


test procedure of the drug product


115 (407)/DRU/DRA.Variation/2019Mircera Pre-filled Syringe

75mcg/0/3ml

Methoxy polyethylene glycol-

epoetin Beta 75mcg/0.3mlBRU14081449P


package insert (Version : PFS-MIR-2019

03, Date of Revision : Mar 2019)

Medipharm Sdn Bhd


Mircera re-filled syringe

glycol-epoetin beta

100mcg/0.3ml




package insert (Version : PFS-MIR-2019

03, Date of Revision : Mar 2019)

Medipharm Sdn Bhd

117 (421)/DRU/DRA.Variation/2019 Varivax (refrigerated)

Varicella Virus Vaccine Live

(Oka / Merck) 1350PFU /

0.5ml

BRU15121972PS1 &

BRU15121972PS2


alternative site for diluent vial

2 - Minor (MiV-PA) - Addition of visual

inspection site and release testing site

for syringe


118 (422)/DRU/DRA.Variation/2019Adenocor Injection

6mg/2mlAdenosine 6mg/2ml BRU09020198P

1 - Minor (MiV-PA10) - Change of re-

test period for drug substanceMedipharm Sdn Bhd

119 (432)/DRU/DRA.Variation/2019Synagis 100mg/ml

Solution for InjectionPalivizumab 100mg/ml BRU18012293P

1 - Minor (MiV-PA2) - Update of S5

Refence Standards or Materials Zuellig Pharma (B) Sdn Bhd

120 (433)/DRU/DRA.Variation/2019 Diflucan Capsule 50mg Fluconazole 50mg BRU10040443P


package insert (date of revision : 06

Oct 2017, version : DIFLUCAN-1017)

2 - Minor (MiV-PA) - Update of CEP for

Gelatin








Gelatin







Gelatin







124 (437)/DRU/DRA.Variation/2019 Daivonex® OintmentCalcipotriol 50mcg/g (0.005%

w/w)BRU13010995P


package insert (date of revision :

March 2019)


125 (438)/DRU/DRA.Variation/2019Targin Prolonged Release

Tablets 5mg/2.5mg

Each Tablet contains:

4.5MG of oxycodone as 5mg

oxycodone hydrochloride

2.25mg of naloxone as 2.5mg

naloxone hydrochloride

BRU17022153P

1 - Minor (MiV-PA2) -Change of outer


[Version : 2 Mar 2018 (based on CCDS

V9 & AYS PI-15 September 2017]

2 - Minor (MiV-PA12) - Revision of

European Certificate of Suitability (CEP)

of drug substance, oxycodone

hydrochloride


126 (439)/DRU/DRA.Variation/2019targin Prolonged Release

Tablets 10mg/5mg


9MG of oxycodone as 10mg


4.55mg of naloxone as 10mg


4.5mg of naloxone as 5mg


BRU17022154P








hydrochloride


127 (440)/DRU/DRA.Variation/2019Targin Prolonged release

Tablets 20mg/10mg


18MG of oxycodone as 20mg


9mg of naloxone as 10mg


BRU17022155P








hydrochloride



128 (441)/DRU/DRA.Variation/2019Targin Prolonged release

Tablets 40mg/20mg


36mg of oxycodone as 40mg


18mg of naloxone as 20mg


BRU17022156P








hydrochloride


129 (442)/DRU/DRA.Variation/2019Oxycontin® Controlled

Release Tablets 10mg

Oxycodone hydrochloride

10mgBRU17072228P



[Version : 3-3684-0E, date of revision:

23 October 2015)





20mgBRU17072229P




23 October 2015)





40mgBRU17072230P




23 October 2015)





80mgBRU17072231P




23 October 2015)


133 (446)/DRU/DRA.Variation/2019 Glucobay 50 Tablet Acarbose 50mg BRU09020212P

1 - Minor (MiV-PA12) -Revision of


of Suitability (CEP) of drug substance

2 - Minor (MiV-PA27) and MiV-PA -

Change in the test pocedure of drug

product, including editorial changes to

container closure system documents of

drug product


134 (447)/DRU/DRA.Variation/2019 Glucobay Tablet 100mg Acarbose 100mg BRU09050252P

1 - Minor (MiV-PA12) -Revision of



2 - Minor (MiV-PA27) and MiV-PA -

Change in the test pocedure of drug

product, including editorial changes to

container closure system documents of

drug product



Epilim Chrono 500mg

Scored Film-coated

Tablet

Sodium valproate 500mg

(Sodium valproate 333mg &

Valproic acid 145mg)

BRU10070521P

1 - Minor (MiV-PA2) -Change in outer


(Revision date : 15 Nov 18 / CCDS 23 /

SmPC 19 Oct 18)

Medipharm Sdn Bhd


136 (449)/DRU/DRA.Variation/2019Epilim ® 200 Enteric

Coated TabletsSodium Valproate 200mg BRU11120839P



(Revision date : 15 Nov 18 / CCDS 23 /

SmPC 19 Oct 18)

Medipharm Sdn Bhd

137 (450)/DRU/DRA.Variation/2019Epilim Intravenous

400mg/vialSodium Valproate 400mg BRU09080296P



(revision date : 15 Nov 18 / CCDS 23 /

SmPC 19 Oct 18)


storage conditions of the drug product


storage condition)

Medipharm Sdn Bhd

138 (451)/DRU/DRA.Variation/2019 Noxafil 100mg tablet Posaconazole 100mg BRU16072058P


package insert (Version : S-SG-MTL-

032019, Revision date : May 2019)


139 (458)/DRU/DRA.Variation/2019Rocaltrol capsule

0.25mcgCalcitriol 0.25mcg BRU16022006P

1 - Minor (MiV-12) - Revision of



Hongkiat Trading &

Company

140 (459)/DRU/DRA.Variation/2019 Ravimed Tablet 5mgMedroxyprogesterone

actetate USP 5mgBRU17092254P



(revision date : 15.05.2019)




storage condition)

3 - Minor (MiV-N9) - Change of release

and shelf-life specifications of the drug

product, following updates in the

comoendium

4 - Minor (MiV-N10) - Deletion of pack

size for a product

Hongkiat Trading &

Company

141 (462)/DRU/DRA.Variation/2019 Drapolene Cream

Cetrimide 0.2% w/w,

Benzalkonium Chloride

Solution 0.92% w/w (equiv. to

Benzalkonium Chloride 0.01%

w/w)

BRU12060915NP


release and shelf-life specifications of

the drug product

2 - Minor (MiV-PA35) with

consequential MiV-PA2 - Change of



storage condition) with consequential

change in product labelling ( inner


date of revision June 2018)

Kingston Beverage &

Creamery Sdn Bhd


Zaltrap™ Concentrate for

Solution for infusion

25mg/ml (4ml/vial)



package insert (revision date : May

2018)

Medipharm Sdn Bhd



Zaltrap™ Concentrate for

Solution for infusion

25mg/ml (8ml/vial)



package insert (revision date : May

2018)

Medipharm Sdn Bhd

144 (473)/DRU/DRA.Variation/2019Betadine® Antiseptic Skin

Cleanser 7.5% w/vPovidone-Iodine 7.5% w/v BRU16122122NP


labelZuellig Pharma (B) Sdn Bhd


Betadine Feminine Wash

Douching Apparatus 10%

w/v

Povidone-Iodine 7.5% w/v BRU16011994NP



insert (date of revision : May 2012

(CCDS ver. November 2006)


146 (475)/DRU/DRA.Variation/2019 Betadine Feminine Wash Povidone-Iodine 10% w/v BRU16011995NP



insert (date of revision : May 2012

(CCDS ver. November 2006)


147 (476)/DRU/DRA.Variation/2019Betadine Antiseptic

ointmentPovidone -Iodine 10% w/w BRU16011993NP


label and outer carton labelZuellig Pharma (B) Sdn Bhd

148 (477)/DRU/DRA.Variation/2019Betadine Gargle and

MouthwashPovidone-Iodine 1% w/v BRU18082384NP



149 (478)/DRU/DRA.Variation/2019Betadine® Dry Powder

Spray 2.5%Povidone-Iodine 2.5% BRU16122120NP



150 (479)/DRU/DRA.Variation/2019 Cataflam® 50 Tablet Diclofenac Potassium 50mg BRU09090318P


package insert (Tracking number : 2017-

PSB/GLC-0910-s, date of revision : 5

Feb 2018)


151 (481)/DRU/DRA.Variation/2019 Xalacom Eye Drops

1ml contains latanoprost 50

micrograms and timolol

maleate 6.8mg (eq to 5mg

timolol)

BRU15081914P


package insert (Version: Xalacom-1118,

date of revision : 23 Nov 2018)


152 (488)/DRU/DRA.Variation/2019 T3 Mycin GelClindamycin (as phosphate)

1.0%BRU09040243P

1 - Major (MaV-8) - Change of batch

size of non-sterile drug product


carton label and package insert (Date

of revision: Feb 2014)

3 - Minor (MiV-PA15) - Quantitative

change of excipient (Sodium

hydroxide)

G&H Trading Company

153 (489)/DRU/DRA.Variation/2019 Anacaine Injection 1% Lidocaine Hydrochloride 1% BRU17052205P


package insert (Date of revision:

18.09.2018)

G&H Trading Company


Ovidrel Solution for

Injection 250mcg/0.5ml

in Pre-filled Syringe

Choriogonadotropin alfa

250mcg/0.5mlBRU13101155P




G&H Trading Company

155 (492)/DRU/DRA.Variation/2019Nasonex Aqueous Nasal

Spray 0.05%

Mometasone furorate

monohydrate, micronized

0.05%

BRU12040889P1 - Minor (MiV-PA14) - Removal or

reduction of overageZuellig Pharma (B) Sdn Bhd


156 (496)/DRU/DRA.Variation/2019Lamictal Dispersible

Tablet 5mgLamotrigine 5mg BRU12050898P


package insert (version : Lamictal v06,

reference: GDS46/IPI123, Revision

Date : 15 May 2019)



Lamictal

Dispersible/Chewable

Tablet2 5mg

Lamotrigine 25mg BRU14031280P

1 - Minor (MiV-PA2) - Change in blister


insert (Version: Lamictal v06,

Reference: GDS46/IPI23, Revision Date

: 15 May 2019



(Increasing from the current approved

storage condition)


158 (498)/DRU/DRA.Variation/2019 Lamictal 100mg Tablet Lamotrigine 100mg BRU14081441P


package insert (version : Lamictal v06,

reference: GDS46/IPI123, Revision

Date : 15 May 2019)



No Application Variation Ref. No. Product Name Active ingredientsProduct Registration

No.Variations Company

1 (55)/DRU/DRA.Variation/2014 Concor tablet 2.5mgBisoprolol hemifumarate

2.5mgBRU11100796P


procedure of the drug productZuellig Pharma (B) Sdn Bhd

2 (56)/DRU/DRA.Variation/2014 Concor tablet 5mg Bisoprolol hemifumarate 5mg BRU12010853P1 - MiV-PA27 - Change in the test



Nimenrix™

(Meningococcal

polysaccharide

serogroups a, C, W-135,

Y) Vaccine

MenAah-TT-conjugate (mean

TT/pS ratio:3) 5mcg PSA-15mcg

TT, MenCah-TT-conjugate

(Mean TT/pS ratio:3) 5mcg PSC-

5mcg PSC-15mcg TT, MenW-TT-

conjugate (Mean TT/PS ratio:

1.5) 5mcg PSW-7.5mcgTT,

MenY-TT-conjugate (mean

TT/PS ratio 1.3) 5mcg PST-

6.5mcg TT

BRU15031814P

1 - Major (MaV-2) - Change in package

insert (version NIMENRIX-0619, Date

of Revision: 25 Jun 2019)


4 (60)/DRU/DRA.Variation/2019Atrovent N 20µg/puff

Metered Dose Inhaler

Ipratropium bromide

anydrous 20mcg (as

monohydrate 21mcg)

BRU09080308P

1 - MiV-PA27 - Change in the

specification and test procedure of the

drug product

2 - MiV-PA28 - Update in the document

P7.1 Description of Container Closure

System and an update on Supplier for

Ferrule

Hongkiat Trading &

Company


75mcg/0/3ml



1 - Major (MaV-4) - Addition and

replacement of the manufacturing site

of the drug product

2 - Major (MaV-9) including MaV-7 -

Major change in the manufacturing

process for the drug product including

change in batch size






Medipharm Sdn Bhd

146th DRC Variations (95 applications)



100mcg/0.3ml



1 - Major (MaV-4) - Addition and

replacement of the manufacturing site

of the drug product

2 - Major (MaV-9) including MaV-7 -

Major change in the manufacturing

process for the drug product including

change in batch size






Medipharm Sdn Bhd





contains:




10micrograms

(conjugated to



micrograms)




5micrograms

(conjugated to



micrograms); meninggococcal









CRM197 protein..5.6 to

10.0.micrograms)

BRU14031269P


alternative manufacturer of working

seed storage location for drug

substance (Men-C PS) where European

Pharmacopoeial Certificate of

Suitability (CEP) is not available)


manufacturing process and in-process

controls of the drug substance (MenC)

(where European Pharmacopoeial

Certificate of Suitability (CEP) is not

available)


specification of drug substance (MenC-

CRM conjugate)



substance (Men-C PS and Men-C CRM)







contains:




10micrograms

(conjugated to



micrograms)




5micrograms

(conjugated to













10.0.micrograms)

BRU14031269P




substance (Men-C PS) where European

Pharmacopoeial Certificate of

Suitability (CEP) is not available)


specification of drug substance (MenY-

CRM Conjugate)


specification of drug substance (MenC-

CRM conjugate)



substance (MenY-CRM Conjugate and

MenY-PS)







contains:




10micrograms

(conjugated to



micrograms)




5micrograms

(conjugated to













10.0.micrograms)

BRU14031269P




substance (Purified CRM197) (Where


of Suitability (CEP) is not available



substance (Purified CRM197) (Where

European Pharmacopoeial certificate

of Suitability (CEP) is not available)



substance (Purified CRM197)


10 (192)/DRU/DRA.Variation/2019Saizen Liquid 6mg

(5.83mg/ml)

Somatropin 6mg/1.03ml

(recombinant human growth

hormone)

BRU15031826P



insert, new date of revision May 2018

(based on CCDS V4))

2 - MiV-PA35 - Update of storage


G&H Trading Company

11 (193)/DRU/DRA.Variation/2019Saizen® Liquid 12mg

(8mg/ml)

Somatropin 12mg/1.5ml

(recombinant human growth

hormone)

BRU15031825P



insert, new date of revision May 2018

(based on CCDS V4))

2 - MiV-PA35 - Update of storage


G&H Trading Company

12 (234)/DRU/DRA.Variation/2019 Ferromed Tablet 200mg Ferrous Fumarate BP 200mg BRU17052207NP

1 - MaV-15 - Extension of shelf-life of

the durg product

2- MiV-PA35 - Change of storage


G&H Trading Company


13 (260)/DRU/DRA.Variation/2019Lantus Solostar

100units/mlInsulin Glargine (HOE 901) BRU09110350P


labelling - inner label, outer carton and

package insert, new revision date :

Sept 2017 (CCDS V18 19 based on EU

SmPC Jun 2017)

Medipharm Sdn Bhd

14 (315)/DRU/DRA.Variation/2019 Plavix Tablet 75mgClopidogrel (as Hydrogen

Sulphate) 75mgBRU09010186P


labelling (package insert, new date of

revision: April 2019 (based on SmPC

dated 25 October 2018))

Medipharm Sdn Bhd

15 (316)/DRU/DRA.Variation/2019Co-Plavix® 75/100 film-

coated tablets

Clopidogrel (as Hydrogen

Sulphate) 75mg;

Acetylsalicylic acid 100mg

BRU14021216P


labelling (package insert, new date of

revision: April 2019 (based on

CCDS18/SmPC dated 25 October

2018))

Medipharm Sdn Bhd

16 (326)/DRU/DRA.Variation/2019Giotrif 20mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 20mg BRU15021786P

1 - MaV-1 (inc MiV-PA2) - Change of

indication including change of product

labelling, package insert (new revision

date 14 AUG 2018 version : MY 0281-

08)

2 - MiV-PA Others - Update of

specification and analytical procedure

of the Container Closure System

Hongkiat Trading &

Company







08)




Hongkiat Trading &

Company







08)




Hongkiat Trading &

Company








08)




Hongkiat Trading &

Company

20 (330)/DRU/DRA.Variation/2019 Aromasin 25mg Tablet Exemestane 25mg BRU10030426P

1 - MaV -2 - Change of content of

product labelling (package insert, new

date of revision : 08 Aug 2018 version

AROMASIN-0818)


21 (353)/DRU/DRA.Variation/2019 Prelone Syrup 3mg/5ml Prednisolone BRU09100334P

1 - MiV-PA30 - Change of the container

closure for non-sterile product

2 - MiV-PA34 - Reduction of shelf-life

of the drug product

3 - MiV-PA35 inc MiV-PA2 - Change of


and consequential update in the

package insert SL060R10 (Revised

Date: 27/10/2017)

G&H Trading Company

22 (354)/DRU/DRA.Variation/2019 Halaven mesilate Eribulin mesilate BRU18092408P

1 - Major (MaV-1) including (MiV-PA2 ) -

Additional indication extending the

usage of the product and change of

package insert (Date of revision : May

2018)

Medipharm Sdn Bhd

23 (358)/DRU/DRA.Variation/2019 Tegretol 2% Syrup Carbamazepine 100mg/5ml BRU11020647P

1 - MaV-3- -Addition of alternative


CEP is not available

2 - MiV-PA Others - Update of starting

material Sodium Cyanate testing

monograph

3 - MiV-PA others - Editorial

amendment in the registered

information on manufacturing process


24 (359)/DRU/DRA.Variation/2019 Tegretol 200mg Tablet Carbamazepine 200mg BRU11020644P






monograph






25 (360)/DRU/DRA.Variation/2019 Tegretol CR 200 Tablet Carbamazepine 200mg BRU11010627P






monograph





26 (361)/DRU/DRA.Variation/2019 Tegretol CR 400 Tablet Carbamazepine 400mg BRU11010627P






monograph





27 (411)/DRU/DRA.Variation/2019 Aceprin 100mg Tablet Aspirin 100mg BRU15061882P


labelling (outer carton, version

VUACE07-var2 and package insert, new

revision date September 2018 VIACE02-

var2)

G&H Trading Company

28 (413)/DRU/DRA.Variation/2019 Hovid Lipiduce-20 TabletAtorvastatin 20mg (as

calcium)BRU14111649P


labelling (outer carton, version

VULIP15-PC (MY) and package insert,

new revision date April 2018 version

VILIPkp-PC (MY)

G&H Trading Company

29 (414)/DRU/DRA.Variation/2019 Loratyn-10 Loratadine 10mg BRU15051878P


labelling (foil label version VFLOR03-1,

outer carton version VULOR17-3 (MY)

and package insert, new date or

revision: April 2017 version VILOR07-0

(MY))



G&H Trading Company


Gonal-F Powder and

Solvent for Solution for

Injection 75IU

(5.5mcg)/vial

Follitrophin Alfa 75 IU

(5.5mcg)BRU13071104P

1 - MiV-PA Others - Replacement of

the Reference House Standard RHS r-

hFSH 2010/01 Bulk to RHS r-hFSH

2016/01

G&H Trading Company


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)

BRU14031256P




2016/01

G&H Trading Company



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)

BRU14031257P




2016/01

G&H Trading Company


Gonal-F 1050IU/1.75ml

(77mcg/1.75ml) Powder

and Solution for Injection

Per Pen (1.75ml) - Follitropin

Alfa 1050IU (equivalent

77mcg) [Per ml of Solution

contains 600IU Follitropin alfa-

44mcg]

BRU14111598PS1 &

PS2




2016/01

G&H Trading Company

34 (430)/DRU/DRA.Variation/2019 Iodosorb OintmentCardexomar Iodine (eq. to

Iodine 0.9%)BRU13071100P

1 - MiV-PA31 - Change of outer pack

sizes for a drug product

Mc. Quipp Technisell

Marketing Sdn Bhd

35 (431)/DRU/DRA.Variation/2019 Iodosorb PowderCadexomer 99.1% w/w/, with

Iodine 0.9% w/wBRU13091135P


labelling of outer carton

Mc. Quipp Technisell

Marketing Sdn Bhd

36 (469)/DRU/DRA.Variation/2019 Duofilm LiquidSalicylic acid 16.7% w/w/;

lactic acid 16.7%BRU15041853P

1 - Major (MaV-4) - Change of the

manufacturing site of the drug product

2 - Minor (MiV-PA1) - Change of drug

product name to Duofilm Solution


37 (499)/DRU/DRA.Variation/2019Exjade 125mg Dispersible

TabletsDeferasirox 125mg BRU12110964P

1 - MiV-PA7 - Minor changes to the

manufacturing process and process

controls of drug substance

2 - MiV-PA8 - Update to drug subtance

testing monograph

3 - MiV-PA -Change in test procedure

for starting material and intermediate


38 (500)/DRU/DRA.Variation/2019Exjade 500mg Dispersible

TabletsDeferasirox 500mg BRU12110965P

1 - MiV-PA7 - Minor changes to the

manufacturing process and process

controls of drug substance

2 - MiV-PA8 - Update to drug subtance

testing monograph

3 - MiV-PA -Change in test procedure

for starting material and intermediate


39 (501)/DRU/DRA.Variation/2019Galvus Met 50/850mg

Film-coated Tablet

Vildagliptin 50mg; Metformin

HCI 850mg (corresponding to

660mg Metformin)

BRU14031275PS1;

PS2



40 (502)/DRU/DRA.Variation/2019Galvus Met 50/1000mg

Film-coated Tablet

Vildagliptin 50mg; Metformin

HCI 1000mg (corresponding

to 780mg Metformin)

BRU14031274PS1;

PS2



41 (503)/DRU/DRA.Variation/2019 Voltaren SR Tablet 100mg Diclofenac sodium 100mg BRU09040242P

1 - MiV-PA19 - Tightening of in-process





42 (504)/DRU/DRA.Variation/2019 Femara 2.5mg Tablet Letrozole 2.5mg BRU11010621P

1 - MiV-N7 - Withdrawal of the

alternative manufacturer (s) for drug

substance

2 - MiV-N6 - Change of the address of a

manufacturer of the drug substance




4 - MiV-PA others - Update of raw

material specifications and test

procedures of strating materials


43 (505)/DRU/DRA.Variation/2019Sandostatin® LAR®

Injection 10mgOctreotide 10mg BRU11040683P


process of the drug substance where




manufacture of the drug substance

where CEP is not available



Injection 20mgOctreotide (as acetate) 20mg BRU11110799P










Injection 30mgOctreotide (as acetate) 30mg BRU11110800P











1 - MiV-PA - Update of drug product

stability data

2 - MiV-PA - Update of drug substance

stability date





stability data


stability date




Injection 30mgOctreotide (acetate) 30mg BRU11110800P


stability data


stability date



Injection 10mgOctreotide 10mg BR