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LAMPIRAN C

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

No Application Variation Ref. No. Product Name Active ingredients Product Licence No. Variations Applicant

1 (278)/DRU/DRA.Variation/2016 Daktarin Oral Gel 2% Miconazole BRU1308116P

1 - MiV-PA2 (Minor) - Change of Product labelling

(Package Insert (Date of revision of text : 2 January 2014);

Inner label & outer carton

Zuellig Pharma (B) Sdn

Bhd

2 (106)/DRU/DRA.Variation/2017 Ritalin LA 20mg CapsulesMethylphenidate

Hydrochloride 20mgBRU10090550P

1 - MiV-PA2 - Update in source of hard capsule gelatin

with the change of product labelling (outer carton and

inner label)


Bhd

3 (107)/DRU/DRA.Variation/2017Ritalin Modified Release

Capsule 30mg

Methylphenidate




inner label)


Bhd

4 (108)/DRU/DRA.Variation/2017Ritalin LA Modified Release

Capsule 40mg

Methylphenidate




inner label)


Bhd

5 (350)/DRU/DRA.Variation/2017Sandostatin LAR Injection

10mgOctreotide BRU11040683P

1 - MiV-PA2 (Minor) - Change of package insert (Updated

package insert:CDS Release Date 11 September 2017;

Date of revision: November 2017)

2 - MiV-PA32 (Minor) - Change in any part of the

(primary) packaging material not in contact with the

finished product formulation

3 - MiV-PA21 (Minor) - Change of specifications of an

excipient, poly (DL-lactide-co-glycolide

4 - MiV-PA22 (Minor) - Chnage of test procedure for an

excipient, poly (DL-lactide-co-glycolide), including

replacement of an approved test procedure by a new

test procedure

4 - MiV-PA (Minor) - Addition of glass syringe supplier


Bhd

AGENDA 4.3 - APPROVED VARIATIONS DURING THE 139th, 140th & 141st DRC MEETING

139th DRC Meeting (198 Applications)

Agenda 4.3 / 32nd BDMCA -Variation of MP 1019 of 88

LAMPIRAN C














test procedure



Bhd














test procedure



Bhd

8 (834)/DRU/DRA.Variation/2017

Ferinject® 50mg Iron/ml

solution for

injection/infusion

Iron 50mg/ml (as ferric

carboxymaltose)BRU14111569P

1 - MaV-4 (Major) - Addition of manufacturing site of

drug product

2 - MiV-PA29 (Minor) - Addition of manufacturer for

secondary packaging

K-Seri Pharma Sdn Bhd


Onbrez Breezhaler 150mcg

Inhalation Powder Hard

Capsule

Indacaterol Maleate BRU14071376P

1 - MiV-PA8 (Minor) - Change of specification of the drug

substance

2 - MiV-PA (Minor) - Change (Addition) of manufacturer

of drug substance intermediate and starting material


Bhd


Onbrez Breezhaler 300mcg

Inhalation Powder Hard

Capsule

Indacaterol Maleate BRU14071377P

1 - MiV-PA8 (Minor) - Change of specification of the drug

substance

2 - MiV-PA (Minor) - Change (Addition) of manufacturer



Bhd


LAMPIRAN C


Ultibro Breezhaler 110/50

mcg Inhalation Powder Hard

Capsule

Indacaterol (as maleate)

110mcg (143 mcg);

Glycopyrronium (as bromide)

50mcg (63mcg)

BRU14121705P

1 - Mav-5 (Major) - Addition of alternative site for

primary packaging (direct contact with drug product)

including secondary packaging, including introduction of

10 capsule blister card

2 - MiV-PA22 (Minor) - Change of a test procedure for an

excipient, including replacement of an approved test

procedure by a new test procedure

3- MiV-PA8 (Minor) - Change of the specification of drug

substance (indacaterol)

4- MiV-PA (Minor) - Change (Addition) of manufacturer


5- MiV-PA (Minor) - Change in primary container/closure

system packaging configuration for NVA237

Pharmaceutical Intermediate (NVA237 PI) / DP

Intermediate packaging


Bhd

12 (958)/DRU/DRA.Variation/2017 Arimidex Tablet 1mg Anastrozole 1mg BRU10100571P

1 - MiV-PA4 including MiV-PA12 (Minor) - Change of

manufacturer of drug substance (where CEP is available)

including Revision of European Pharmacopeial Certificate

of Suitability (CEP) of drug substance


Bhd

13 (97)/DRU/DRA.Variation/2018Pamorelin 3.75mg Powder

for supsension for Injection

Triptorelin (peptide base)

3.75mg equivalent to

triptorelin embonate

BRU17052195P

1 - MaV-6 (Major) - Change of the specification of drug

substance (where European Phramacopoeial Certificate

of Suitability (CEP) is not available

2 - MiV-PA2 (Minor) - Change in package insert (Date of

revision : August 2014)

3 - MiV-PA6 (Minor) - Change of in-process controls

applied during the manufacture of the drug substance

[including tightening and addition of new in-process test

and where European Pharmacopoeial Certificate of

Suitability (CEP) is not available]


applied during the manufacture of the drug product

5 - MiV-PA27 (Minor) - Change in test procedure of the

drug product

Hongkiat Trading &

Company


LAMPIRAN C






BRU17052196P














drug product

Hongkiat Trading &

Company






BRU17052197P














drug product

Hongkiat Trading &

Company

16 (101)/DRU/DRA.Variation/2018Axcel Amlodipine 5mg

Tablet

Amlodipine Besylate

equivalent to Amlodipine 5mgBRU15021762P

1 - MaV-15 (major) - Extension of Shelf life of Drug

Product (to 3 years)Medicorp Sdn Bhd

17 (119)/DRU/DRA.Variation/2018 Strepsils Max Plus Lozenges

Amylmetacresol 0.6mg, 2,4-

Dichlorobenzyl alcohol 1.2mg,

Lignocaine HCI 10mg

BRU14081474P

1 - MiV-PA2 (Minor) - Change in Product Labelling (Outer

Carton, Blister Label and Product Information Leaflet

(new revision date : 19 Sept 2017)


Bhd


LAMPIRAN C

18 (151)/DRU/DRA.Variation/2018 Curam 1000mg Tablet

Amoxycillin 875 (as trihydrate);

clavulanic acid 125mg (as

potassium clavulanate)

BRU15041845P

1 - MaV-6 (Major) including MiV-PA24 (Minor) - Change

of specification of drug product [where European

Pharmacopoeial Certificate of Suitability (CEP) is not

available] including change of release shelf-life

specifications of the drug product

2 - MiV-PA12 (Minor) - Revision of European

Pharmacopoeial Certificate of Suitability (CEP) of drug

substance


drug product

4 - MaV-1 (Major) inlcuding MiV-PA2 (Minor) - Addition

of dosing regimen of the product including change in

outer carton and package insert (Date of revision:JUN

2017 (CDS Feb 2014))

5 - MiV-PA20 (Minor) - Minor change of the

manufacturing process for non-sterile product

6 - MiV-PA35 (Minor) with consequential MiV-PA34 -

Change of storage condition of the drug product

(increasing from the current approved storage condition)

with consequential reduction of shelf-life of the drug

product

7 - MiV-PA - Update of dossier


Bhd

19 (152)/DRU/DRA.Variation/2018Ospamox 250mg/5ml

Granules Oral SuspensionAmoxicillin Trihydrate BRU15011714P


product (where CEP is not available)- Deletion of test

parameter and limit

2 - Mav-16 (Major ) - Change of storage conditions of the

drug (Reconstituted) (Lowering from the current

approved storage condition)

3 - MiV-PA2 (Minor) - Change in product labelling

(package insert, outer carton and inner label)



substance

5 - MiV-PA24 (Minor) - Change of release and shelf-life


6 - MiV-PA27 (Change in the test procedure of the drug

product

7- MiV-PA32 (Minor) - Change in any part of the




Bhd


LAMPIRAN C

20 (182)/DRU/DRA.Variation/2018Praxbind Solution for

Injection/Infusion 50mg/mlIdarucizumab 50mg/ml BRU17062218P

1 - MiV-PA2 (Minor) - Change of package insert (Date of

revision : 23 August 2018)

2 - MaV-15 (Major) - Extension of shelf-life of drug

product

3 - MiV-PA10 (Minor) - Change of shelf-life for drug

substance

4 - MiV-PA35 (Minor) - Change of storage conditions of

the drug product (increasing from the current approved

storage condition)

Hongkiat Trading &

Company

21 (217)/DRU/DRA.Variation/2018 Daktarin Oral Gel 2% Miconazole BRU13081116P

1 - MiV-PA2 (Minor) - Change of product labelling

(updated package insert to CCDS vNov 2016 + RLCP, Date

of revision of text 14 June 2017, inner label & outer

carton)


Bhd

22 (374)/DRU/DRA.Variation/2019 Glucophage® Tablet 850mg Metformin HCl 850mg BRU13010997P

1- MaV-2 (Major) including MiV-PA2 - Change of blister

label, outer carton and package insert (Date of revision:

June 2017 (Based on CCDS V7.0))


Bhd

23 (444)/DRU/DRA.Variation/2018Invokana 100mg Film-

Coated Tablet

Canagliflozin 100mg (as

hemihydrate)BRU14111652P

1 - MaV-4 (Major) with consequential MiV-PA2 - Change

of the manufacturing site of the drug product with

consequential change in blister label, outer label and

package insert (Date of revision: 30 April 2018 (Based on

EU SmPC vMay2017 + RLCP)


Bhd

24 (445)/DRU/DRA.Variation/2018 Invokana 300mg FCTCanagliflozin 300mg (as

hemihydrate)BRU14121699P

1 - MaV-4 (Major) with consequential MiV-PA2 - Change

of the manufacturing site of the drug product with

consequential change in blister label, outer carton label

and package insert (Date of revision : 30 April 2018

(Based on EU SmPC vMay2017 + RLCP)


Bhd

25 (446)/DRU/DRA.Variation/2018Zykadia 150mg Hard

CapsuleCertinib 150mg BRU18012292P

1 - MaV-1 - Change in dosing regimen with an update in

package insert; date of revision : Feb 2018


Bhd

26 (490)/DRU/DRA.Variation/2018Kaletra Film-coated Tablet

200mg/50mg

Lopinavir 200mg; Ritonavir

50mgBRU13021026P

1 - MiV-PA2 (Minor) - Change in package insert (Version :

CCDS03081218, Date of revision: February 2019)


Bhd

27 (498)/DRU/DRA.Variation/2018 Havrix 1440 Vaccine

Inactivated Hepatitis A virus

antigen (HAV), HM175 strain

1440 ELISA Units (EL.U.)/ml

BRU14021215P

1 - MaV-12 (Major) - Addition of primary packaging

material of the sterile drug product

2 - MaV-5 (Major) - Addition or replacement of

alternative site for primary packaging (direct contact with

drug product)


Bhd

28 (499)/DRU/DRA.Variation/2018Engerix-B Paediatric Vaccine

10mcg/0.5mlPurified HBs-Ag 10mcg BRU11040690P



2 - MaV-5 (Major) - Addition or replacement of


drug product)


Bhd

29 (500)/DRU/DRA.Variation/2018Engerix-B Adult Dose

Vaccine 20mcg/ml

Purified Hepatitis B Surface

Antigen (HBsAg) 20mcg/mlBRU11010637P



2 - MaV-5 (Major)- Addition or replacement of


drug product)


Bhd


LAMPIRAN C

30 (502)/DRU/DRA.Variation/2018 Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) BRU14111649P1 - MiV-PA34 - Reduction of shelf-life of the drug product

(to 30 months)G&H Trading Company

31 (508)/DRU/DRA.Variation/2018Pradaxa® Hard Capsules

75mg

Dabigatran etexilate 75mg (as

mesilate 86.48g)BRU14021247P

1 - MiV-PA7 (Minor) including MiV-PA6 and MiV-PA5 -

Change in manufacturing process and in-process control

of drug substance (where European Pharmacopoeial

Certificate of Suitability (CEP) is not available) with

consequential change in batch size.

2 -MiV-PA8 (Minor) including MiV-PA9 - Change of the

specification of drug substance including change of the

test procedures of non-compendial drug substance

3 - MiV-PA (Minor) - Update in manufactures of drug

substance intermediate and testing sites using the 2nd

generation B4 synthesis.

Hongkiat Trading &

Company


110mg














Hongkiat Trading &

Company


150mg














Hongkiat Trading &

Company

34 (553)/DRU/DRA.Variation/2018 Allersin-F Tablet 4mgChlorpheniramine maleate

4mgBRU10060485P

1 - MiV-PA28 (inc MiV-PA2) - Change in primary

packaging material for non-sterile product, with

consequential update in package insert, revised date :

15/01/2014

G&H Trading Company

35 (556)/DRU/DRA.Variation/2018 Fenagesic Capsule 250mg Mefenamic acid 250mg BRU09080309P1 - MiV-PA2 - Change of product labelling (inner label

and package insert; version T030R03)G&H Trading Company


LAMPIRAN C

36 (565)/DRU/DRA.Variation/2018 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

BRU11080747PS1,

BRU11080747PS2,

BRU11080747PS3



(where European Pharmacopoeial Certificate of

Suitability (CEP) is not available

2 - MiV-PA (Minor) - Change in the seed lot system of

Clostridium tetani for the conjugated Haemophilus b

Polysaccharide (PRP-T) production (Addition of an

intermediate seed lot)


Bhd

37 (566)/DRU/DRA.Variation/2018Hexaxim 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

10µg, Haemophilus influenzae

type b polysaccharide

(polyriboslyribitol phosphate).

12µg, conjugated to Tetanus

protein (PRP-T) 22-36µg

BRU15011728P




Suitability (CEP) is not available

2 - MiV-PA (Minor) - Change in the seed lot system of

Clostridium tetani for the conjugated Haemophilus b

Polysaccharide (PRP-T) production (Addition of an

intermediate seed lot)


Bhd

38 (567)/DRU/DRA.Variation/2018 Varilrix™Live attenuated varicella virus

(OKA strain)BRU11100790P

1 - MaV-10 (Major) - Qualitative change of the excipient

2 - MiV-PA2 (Minor) - Change in outer carton label, inner

label and package insert (Version: 02, Reference:

GDS14/IPI16, Date of revision : 02 May 2019)


Bhd

39 (568)/DRU/DRA.Variation/2018 Rotarix™ oral suspensionHuman rotavirus RIC4414

strain, not less than 10 CCIDBRU12070924P

1 - MiV-PA9 (Minor) - Chang e of test procedure of non-

compendial drug substance

2 - MiV-PA27 (Minor) - Change in the test procedure of

the drug product


Bhd


LAMPIRAN C

40 (569)/DRU/DRA.Variation/2018 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

BRU11070729P

1 - MaV-3 (Major) - Addition of alternative manufacturer


Certificate of Suitability (CEP) is not available)

2 - MiV-PA9 (Minor) - Change of test procedure of non-



Bhd

41 (572)/DRU/DRA.Variation/2018 Telfast 180mg Tablet Fexofenadine HCI 180mg BRU10050478P

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

carton, blister label and package insert, new date of

revision: May 2017)

Medipharm Sdn Bhd

42 (573)/DRU/DRA.Variation/2018 Sunex Cough Syrup

Per 5ml - Diphenhydramine

HCI 14mg; Ammonium

chloride 135mg;

Sodium/Trisodium citrate

57.5mg

BRU14081453P

1 - MiV-PA2 (Minor) - Change of product labelling (inner

label and package insert, new date of revision May 2017)



storage condition)

G&H Trading Company

43 (575)/DRU/DRA.Variation/2018Azopt Eye Drops,

Suspension

Brinzolamide 10mg/ml

(1.0%w/w)BRU1302105P


applied during the manufacture of the drug susbtance

(including tighening and addition of new in-process test

and where CEP is not available

2 - MiV-PA7 (Minor)- Change of manufacturing process of

the drug substance (where CEP is not available)


Bhd

44 (576)/DRU/DRA.Variation/2018Azarga Eye Drops

Suspension

Brinzolamide 10mg/ml ;

Timolol maleate 5mg/mlBRU17022146P



(inlcuding tightening and addition of new in-process test

and where CEP is not available)

2 - MiV-PA7 (Minor) - Change of manufacturing process

of the substance (where CEP is not available)


Bhd

45 (577)/DRU/DRA.Variation/2018Lucentis 10mg/ml Solution

for InjectionRanibizumab 10mg/ml BRU14071375P


excipient (trehalose dihydrate)

2- MiV-N (Minor) - Addition of bioburden test to the

biologic drug substance (DS) release specification with

corresponding test method


Bhd

46 (578)/DRU/DRA.Variation/2018Prostin VR Paediatric Sterile

Solution %00mcgAlprostadil 500mcg/ml BRU10080532P

1 - MiV-PA2 (Minor)- Change of product labelling

(package insert, new date of revision : 09 March 2018)


Bhd


LAMPIRAN C

47 (581)/DRU/DRA.Variation/2018Axcel Eryhthromycin ES

Tablet 400mg

Erythromycin (as ethyl

succinate) 400mgBRU08110154P

1 - MaV-6 (Major) (inc MiV-PA24) - Change of the

specification of drug product (inlcuding change of release

and shelf life specifications of the drug product)


the drug product

3 - MiV-PA34 (Minor) - Reduction of shelf-life of the drug

product (to 1 year)

Medicorp Sdn Bhd

48 (600)/DRU/DRA.Variation/2018 Pentaxim Vaccine

Composition of final container











10µg

BRU11080747PS1,

BRU11080747PS2 &

BRU11080747PS3



(addition of new in-process test and where CEP is not

available)

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

non-compendial drug substance


Bhd

49 (601)/DRU/DRA.Variation/2018Hexaxim Suspension for

Injection

Diptheria, Tetanus, Pertussis

(Acellular, Component),

Hepatitis B (rDNA),

Poliomyelitis (Inactivated) and

Haemophilus influenza Type B

Conugated Vaccine

BRU15011728P



(addition of new in-process test and where CEP is not

available)




Bhd

50 (605)/DRU/DRA.Variation/2018 Cellcept Tablet 500mg Mycophenolate mofetil 500mg BRU114111627P1 - MiV-PA2 (Minor) - Change of package insert (Version :

INF/ORAL-CEL-2018 04-0, Date of revision : Apr 2018)

Hongkiat Trading &

Company

51 (606)/DRU/DRA.Variation/2018Forxiga 5mg Film-Coated

TabletDapagliflozin 5mg BRU17082234P

1 - MiV-PA2 (Minor) - Change of package insert (Version :

[Doc ID-002317198, Version 13.0], Date of revision: April

2018)


Bhd

52 (607)/DRU/DRA.Variation/2018Forxiga 10mg Film-Coated

TabletDapagliflozin 10mg BRU17082235P

1 - MiV-PA2 (Minor) - Change of package insert (Version :

[Doc ID-002317198, Version 13.0], Date of revision: April

2018)


Bhd

53 (608)/DRU/DRA.Variation/2018 Crestor 5mg tablet Rosuvastatin Calcium 5mg BRU09030222P 1 - MiV-PA2 (Minor) - Change in outer carton labelZuellig Pharma (B) Sdn

Bhd


Bhd


Bhd


LAMPIRAN C


Ventolin Solution for

Intravenous Infusion

5mg/5ml

Salbutamol (as sulphate)

5mg/5mlBRU11050704P



Certificate of Suitability (CEP) is not available) & update

to registration dossier for drug substance (S1-S7)


Bhd

57 (612)/DRU/DRA.Variation/2018Ventolin Nebules

2.5mg/2.5ml

Salbutamol Sulphate

2.5mg/2.5mlBRU09100335P

1 - MiV-PA24 (Minor) inc MiV-PA27 - Change of release

and shelf-life specification of the drug product including

test procedures


Bhd

58 (615)/DRU/DRA.Variation/2018Neupogen Pre-Filled Syringe

30MU/0.5mlFilgrastin 30mu/0.5ml BRU14011209P


carton)Medipharm Sdn Bhd

59 (616)/DRU/DRA.Variation/2018Neulastim Pre-filled Syringe

6mg/0.6mlPegfilgrastim 6mg/0.6ml BRU15021766P


carton)Medipharm Sdn Bhd

60 (617)/DRU/DRA.Variation/2018Mircera Pre-filled Syringe

75mcg/0.3ml

Methoxy polyethylene glycol-

epoetin Beta 75mcg/0.3mlBRU14081449P


carton)

2 - MiV-PA8 (Minor) - Change of the specification of drug

subtance

Medipharm Sdn Bhd

61 (618)/DRU/DRA.Variation/2018Mircera Pre-filled Syringe

100mcg/0.3ml

Methoxy polyethylene glycol-

epoerin Beta 100mcg/0.3mlBRU16022003P


carton)


subtance

Medipharm Sdn Bhd

62 (620)/DRU/DRA.Variation/2018 Xanax™ 0.25mg Tablet Alprazolam 0.25mg BRU09070283P1 - MiV-PA2 (Minor) - Change of package insert (Version:

Xanax-0218, Date or revision: 19 Feb 2018)


Bhd

63 (621)/DRU/DRA.Variation/2018 Xanax™ 0.5mg Tablet Alprazolam 0.5mg BRU09070286P1 - MiV-PA2 (Minor) - Change of package insert (Version:



Bhd

64 (622)/DRU/DRA.Variation/2018 Xanax™ 1mg Tablet Alprazolam 1mg BRU09100339P1 - MiV-PA2 (Minor) - Change of package insert (Version:



Bhd

65 (623)/DRU/DRA.Variation/2018Caelyx 2mg/ml Concentrate

for infusionDoxorubicin HCI 2mg/ml

BRU11030669PS1,

BRU11030669PS2

1 - MiV-PA2 (Minor) - Change of inner label and outer

carton label


Bhd

66 (624)/DRU/DRA.Variation/2018Depo-Provera Vial

150mg/3ml

Medroxprogesterone acetate

150mgBRU11050701P

1 - MiV-PA24 (Minor) including MiV-PA27 - Change of

release and shelf-life specifications of the drug product

including change in test procedure of the drug product


Bhd

67 (625)/DRU/DRA.Variation/2018Zyvox Infusion Bag

600mg/300mlLinezolid 600mg/300ml BRU10050471P

1 - MiV-PA2 (Minor) - Change of inner bag label,

aluminium overwrap label and package insert (Version:

ZYVOX-0817, Date of revision: 11 Aug 2017)

2- MiV-PA27 (Minor) - Change in the test procedure of

the drug product

3- MiV-PA35 (Minor) - Change of storage conditions of

the drug product (Increasing from the current approved

storage condition)

4- MiV-N4 (Minor) - Change of the name and address of a

manufacturer of the drug product


Bhd

68 (626)/DRU/DRA.Variation/2018Zyvox film-coated tablet

600mgLinezolid 600mg BRU10060502P

1 - MiV-PA2 (Minor) - Change of package insert (version:

ZYVOX-0817, Date of revision; 11 Aug 2017)


Bhd


LAMPIRAN C

69 (627)/DRU/DRA.Variation/2018Zyvox 20mg/ml Granules

For Oral SuspensionLinezolid 100mg/5ml BRU14111586P

1 - MiV-PA2 (Minor) - Change of package insert (Version:

ZYVOX-0817, Date of revision; 11 Aug 2017)


Bhd

70 (628)/DRU/DRA.Variation/2018 Singulair Tablet 4mgMontelukast 4mg (as sodium

4.16mg)BRU10090539P


SG-MK0476-MF062018, Date of revision:Aug 2018)


Bhd

71 (629)/DRU/DRA.Variation/2018 Singulair Oral Granules 4mgMontelukast Sodium (free acid

equivalent) 4mg

BRU10090542PS1,

BRU10090542PS2




Bhd

72 (630)/DRU/DRA.Variation/2018 Singulair® Tablet 10mgMontelukast (as sodium) 10

mgBRU10070516P




Bhd

73 (631)/DRU/DRA.Variation/2018Singulair® Chewable Tablet

5mgMontelukast (as sodium) 5mg BRU10070517P




Bhd

74 (632)/DRU/DRA.Variation/2018 Motilium tablets 10mg Domperidone 10mg BRU14021218P

1 - MaV-2 (Major) - Change of package insert with

adiministrative update in storage condition (Date of

revision : 18 April 2018 (Based on CCDS vJan2018))


Bhd

75 (633)/DRU/DRA.Variation/2018Motilium Suspension

1mg/mlDomperidone 1mg/ml BRU14031267P

1 - MaV-2 (Major) - Change of package insert with

adiministrative update in storage condition (Date of


Bhd

76 (635)/DRU/DRA.Variation/2018Alphagan P Othalmic

Solution 0.15%Brimonidine tartrate 0.15% BRU14071382P

1 - MiV-PA2 (Minor) - Change of inner label, Outer carton

label and package insert (Version : 91773MY_INT_01,

date of revision; April 2014)

Medipharm Sdn Bhd

77 (636)/DRU/DRA.Variation/2018Recormon Pre-filled Syringe

2000IU/0.3ml

Eryhropoetin Beta

2,000iu/0.3mlBRU13031045P

1 - MiV-PA2 (Minor) - Change of Outer carton l and

package insert (Version : PFS-REC-2018 06, date of

revision: June 2018)

Medipharm Sdn Bhd

78 (637)/DRU/DRA.Variation/2018Recormon Pre-filled Syringe

4000IU/0.3ml

Erythropoetin Beta

4,000iu/0.3mlBRU13031047P

1 - MiV-PA2 (Minor) - Change of Outer carton l and

package insert (Version : PFS-REC-2018 06, date of

revision: June 2018)

Medipharm Sdn Bhd


Botox (Botulinium Toxin,

Type A) Injection

50units/vial

Clostridium Botulinium Toxin

Type A Purified Neurotoxin

Complex 50units/vial

BRU14111624P

1 - MaV-7 (Major) - Change of batch size of sterile drug

product

2 - MaV-9 (Major) - Major change in the manufacturing

process for the drug product

3 - MiV-PA2 (Minor) - Change of outer carton and

package insert (Date of revision: Oct 2017)

Medipharm Sdn Bhd



Type A) Injection

100units/vial




BRU14111623P


product





Medipharm Sdn Bhd



Type A) Injection

200units/vial




BRU14111625P


product





Medipharm Sdn Bhd


LAMPIRAN C

82 (641)/DRU/DRA.Variation/2018Heparinised Saline Injection

10iu/ml (5ml)

Heparin Sodium (Bovine

Mucosa) 10i.u/mlBRU13121189P

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

2 - MaV-13 (Major) - Addition of shape of container for

sterile liquid drug product

Hongkiat Trading &

Company

83 (642)/DRU/DRA.Variation/20180.9% Sodium Chloride

Injection, B.P.(10ml)Sodium Chloride 0.9% BRU14091511NP

1 - MiV-PA2 (Minor) - Update of MAH address on outer

carton

2 - MaV-13 (Major) - Addition of shape of container for

sterile liquid drug product

Hongkiat Trading &

Company

84 (645)/DRU/DRA.Variation/2018Pataday Olopatadine

Opthalmic Solution 0.2%

Olopatadine hydrochloride

2.22mg (eq. to Olopatadine

2mg (0.2%)

BRU14121677P

1 - MaV-3 (Major) - Change of manufacturer of drug

substance (where European Pharmacopoeial Certificate

of suitability (CEP) is not available)


Bhd

85 (646)/DRU/DRA.Variation/2018Patanol® Eye Drops,

Solution 0.1%Olopatadine (as HCI) 0.1%

BRU14031263P;

BRU14031263PS2

1 - MaV-3 (Major) - Change of manufacturer of drug

subtance (where European Pharmacopoeial Certificate of

suitability (CEP) is not available)


Bhd

86 (647)/DRU/DRA.Variation/2018Edurant Film-Coated 25mg

tablet

Rilpivirine (as hydrochloride)

25mgBRU14121698P


of drug substance (where European pharmacopoeial

Certificate of Suitablility (CEP) is not available)


Bhd

87 (649)/DRU/DRA.Variation/2018Vigamox Ophthalmic

Solution 0.5%

Moxifloxacin 0.5% (as

hydrochloride)

BRU14071399PS1;

BRU14071397PS2

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

carton, blister label and package insert, new date of

revision June 2018)


Bhd

88 (650)/DRU/DRA.Variation/2018Pegasys Pre-filled Syringe

180mcg/0.5ml

Peginterferon alfa-2a

180mcg/0.5mlBRU13041058P

1 - MaV-15 (Major)- Extension of shelf-life of the drug

product (to 48 months)



(including tightening & addition of new in-process test

and where CEP is not available

3 - MiV-10 (Minor) - Change of shelf-life or retest period

for drug substance

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


Iinlcuding tightening and addition of new in-process test)

Hongkiat Trading &

Company

89 (651)/DRU/DRA.Variation/2018 Kytril 1mg film coated tablet Granisetron 1mg (as HCI) BRU13041060P1 - MiV-PA3 (Minor)- Replacement of the company or

party responsible for batch release

Hongkiat Trading &

Company

90 (652)/DRU/DRA.Variation/2018 Kytril for Infusion 1mg/ml

Granisetron 1mg (equivalent

to Granisetron hydrochloride

1.12mg)

BRU14041306P1 - MiV-PA3 (Minor)- Replacement of the company or


Hongkiat Trading &

Company

91 (653)/DRU/DRA.Variation/2018 Kytril for Infusion 3mg/3mlGranisetron 3mg (as HCI

3.36mg)BRU13061074P

1 - MiV-PA3 (Minor) - Replacement of the company or


Hongkiat Trading &

Company

92 (654)/DRU/DRA.Variation/2018FML Liquidfilm Sterile

Opthalmic Solution 0.1%Fluorometholone 0.1%w/v BRU13010993P

1 - MiV-PA2 - Change of product labelling (inner label,

outer carton and paclage insert, new date of revision :

March 2018)

Medipharm Sdn Bhd


LAMPIRAN C

93 (655)/DRU/DRA.Variation/2018Extraneal Peritoneal Dialysis

Solution 75g/l (2L Ultrabag)

Each 100ml contains Icodextrin

7.5g, Sodium Chloride 538mg,

Sodium lactate 448mg, calcium

chloride dihydrate 25.7mg and

Magnesium Chloride

Hexahydrate 5.08mg

BRU15011744P1 - MiV-PA8 (Minor) - Change of the specification of drug

substance, sodium lactate


Bhd


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

Hexydrate 5.08mg

BRU15021800NP1 - MiV-PA8 (Minor) - Change of the specification of drug



Bhd


Dianeal Low Calcium



Dextrose (2L Ultrabag and

2.5L Ultrabag)


Hydrous 1.5g; Sodium Chloride

538mg; Sodium Lactate

448mg; Calcium Chloride

dihydrate 18.3mg; and

Magnesium Chloride

Hexydrate 5.08mg




Bhd


Dianeal Low Calcium



Dextrose (2L Ultrabag)


Hydrous 4.25g; Sodium

Chloride 538mg; Sodium

Lactate 448mg; Calcium

Chloride dihydrate 18.3mg;

and Magnesium Chloride

Hexydrate 5.08mg




Bhd

97 (659)/DRU/DRA.Variation/2018 Vaminolact Solution

Per 100ml: L-Alanine 6.3g; L-

Arginine 4.1g; L-Aspartic Acid

4.1g; L-Cysteine / L-Cysteine

1g; L-Glutamic Acid 7.1g;

Glycine (Amino Acetic Acid)

2.1g; L-Histidine 2.1g; L-

Isoleucine 3.1g; L-Leucine 7g; L-

Lysine 5.6g;L-Methionine 1.3g;

L-Phenylalanine 2.7g; L-Proline

5.6g; L-Serine 3.8g; Taurine

300mg; L-Threonine 3.6g; L-

Trytophan 1.4g; L-Tyrosin

500mg; L-Valine 3.6g

BRU14111581P

1 - MiV-PA35 (Minor) (inc MiV-PA2) - Change of storage

conditions of the drug product (increasing from the

current approved storage condition); including change of

product labelling (inner label)


Bhd


LAMPIRAN C

98 (660)/DRU/DRA.Variation/2018Extraneal Peritoneal Dialysis

Solution 75g/L

Per 100ml: Icodextrin 7.5mg;

Sodium Chloride 538mg;

Sodium Lactate 448mg;

Calcium Chloride 25.7,g;

Magnesium Chloride 5.08mg

BRU13021011P1 - MiV-PA8 (Minor) - Change of the specification of drug

substance, sodium lactate Medipharm Sdn Bhd


Dianeal Low Calcium

(2.5mEq/L) Pertoneal

Dialysis Solution with 1.5%

Dextrose

Each 100ml contains; Calcium

Chloride 18.3mg; Dextrose

hydrous 1.5g; Magnesium

Chloride 5.08mg;Sodium


lactate 448mg




Dianeal Low Calcium



Dextrose

Dextrose 2.5g, Sodium


Lactate 448mg; Calcium

duhydrate 18.3mg;

Magnesium Chloride

Hexhydrate 5.08mg




Dianeal Low Calcium



Dextrose

Per 100ml contains Calcium

Chloride 18.3mg; Dextrose

hydrous 4.25g; Magnesium

Chloride 5.08mg; Sodium

Chloride 538mg, Sodium

Lactate 448mg



102 (664)/DRU/DRA.Variation/2018Jardiance 10mg Fim-coated

TabletEmpagliflozin 10mg BRU17022148P

1 - MaV-3 (Major) - Change and/or addition of

alternative manufacturer/site of drug substance (where

CEP is not available)

2 - MiV-PA2 (Minor) - Change or addition of batch size for

BI 10773 XX unmilled (compound VIII unmilled)

Hongkiat Trading &

Company

103 (665)/DRU/DRA.Variation/2018Jardiance 25mg Film-coated


1 - MaV-3 (Major) - Change and/or addition of

alternative manufacturer/site of drug substance (where

CEP is not available)

2 - MiV-PA2 (Minor) - Change or addition of batch size for

BI 10773 XX unmilled (compound VIII unmilled)

Hongkiat Trading &

Company

104 (666)/DRU/DRA.Variation/2018Naphcon-A Sterile

Opthalmic Solution

Naphazoline Hydrochloride

0025%; Pheniramine maleate

0.3%

BRU14081440P

1 - MiV-PA14 (Minor) - Reduction or removal of overage




the drug product



Hongkiat Trading &

Company

105 (667)/DRU/DRA.Variation/2018 Propecia 1mg Tablet Finasteride 1mg BRU11060722P

1 - MiV-PA2 (Minor) - Change of product labelling -

package insert (PI) & patient information leaflet (PIL);

new date of revision July 2018


Bhd


LAMPIRAN C

106 (668)/DRU/DRA.Variation/2018 Proscar Tablets 5mg Finasteride 5mg BRU10090554P1 - MiV-PA2 (Minor) - Change of product labelling -

package insert (PI); new date of revision July 2018


Bhd

107 (669)/DRU/DRA.Variation/2018Novorapid Flexpen

100IU/ml

1ml of solution contains 100IU

insulin aspart (r-DNA)

(equivalent to 3.5mg)

BRU14021219PS1;

BRU14021219PS2;

BRU14021219PS3

1 - MaV-16 (Major) (inc MiV-PA2) - Change of storage

conditions of the drug product (Lowering from the

current approved storage condition) including change of

product labelling (outer carton, package insert, new date

of revision : April 2018)


Bhd

108 (670)/DRU/DRA.Variation/2018 Premarin Tablet 0.3mg Conjugated estrogens 0.3mg BRU14071337P

1 - Mav-3 (Major) (inc MiV-N7) - Change of alternative

manufacturer/site of drug substance (where CEP is not

available); including withdrawal/deletion of the

alternative manufacturer(s) for drug substance

2 - MiV-N6 (Minor) - Change of the name of a

manufacturer of the drug substance


Bhd

109 (671)/DRU/DRA.Variation/2018 Premarin Tablet 0.625mg Conjugated Estrogens 0.625mg BRU13101160P

1 - Mav-3 (Major) (inc MiV-N7) - Change of alternative

manufacturer/site of drug substance (where CEP is not

available); including withdrawal/deletion of the

alternative manufacturer(s) for drug substance

2 - MiV-N6 (Minor)- Change of the name of a

manufacturer of the drug substance


Bhd

110 (672)/DRU/DRA.Variation/2018 Lyrica Capsules 50mg Pregabalin 50mg BRU12100949P1 - MiV-PA (Minor) - Change to Pregabalin API secondary

container closure system


Bhd

111 (673)/DRU/DRA.Variation/2018 Lyrica Capsules 75mg Pregabalin 75mg BRU12060909P1 - MiV-PA (Minor) - Change to Pregabalin API secondary



Bhd

112 (674)/DRU/DRA.Variation/2018 Lyrica Capsules 150mg Pregabalin 150mg BRU12020870P1 - MiV-PA (Minor)- Change to Pregabalin API secondary



Bhd

113 (675)/DRU/DRA.Variation/2018 Zavedos CS Injection vialsIdarubicin hydrochloride

1mg/mlBRU12020867P

1 - MaV-2 (Major) - Change of content of product

labelling (package insert, new date of revision 28

December 2018, ZAVEDOS CS-1218)


Bhd

114 (676)/DRU/DRA.Variation/2018Pristiq 50mg Extended-

Release Tablets

Desvenlafaxine 50mg (as

succinate 75.87mg) BRU14111591P

1 - MiV-PA2 (Minor) - Change of package insert (LPD

date : 18 october 2016, Version: PRISTIQ-1016)


Bhd


Eligard® Powder and solvent

for solution for Injection

7.5mg

Leuprorelin Acetate 7.5mg

(quivalent to 6.96mg

leuprorelin) (syringe B) Solvent

(Syringe A):Poly (DL-lactic-co-

glycolic-acid) (50:50) and N-

methylpyrrolidine

BRU18062353P1 - MiV-PA2 (Minor) - Change of outer carton and

package insert (issue date: Apr 2018)Medipharm Sdn Bhd




22.5mg

Leuprorelin Acetate 22.5 mg

(equivalent to 20-87 mg


(Syringe A) :

Poly (DL-lactic-co-glycolic-acid)

(75.25) and N-

methylpyrrolidine




LAMPIRAN C




45mg

Leuprorelin Acetate 45mg

(equivalent to 41.7 mg


(Syringe A) :

Poly (DL-lactic-co-glycolic-acid)

(85:15) and N-

methylpyrrolidine



118 (681)/DRU/DRA.Variation/2018Duavive 20mg/0.45mg

Modified-Release Tablets

Bazedoxifene acetate

equivalent to 20mg

bazedoxifene; and Conjugated

estrogens 0.45mg

BRU18042337P1 - MiV-PA2 (Minor) - Change of package insert (Revision

date: 13 March 2018, Version: DUAVIVE-0318


Bhd

119 (682)/DRU/DRA.Variation/2018Synagis 100mg/ml Solution

for InjectionPalivizumab 100mg/ml BRU18012293P 1 - MiV-PA2 (Minor) - Change of outer carton


Bhd

120 (683)/DRU/DRA.Variation/2018 Gilenya 0.5mg hard capsule

Fingolimod 0.5mg

(corresponding to 0.56mg

Fingolimod Hydrochloride)

BRU15021771P1 - MiV-PA2 (Minor) - Change of package insert (Version:

2017-PSB/GLC0901-s, Date of revision: May 2018)


Bhd

121 (684)/DRU/DRA.Variation/2018 Tykerb™ tablets 250mgLapatinib 250mg (as ditosylate

monohydrate)BRU14021233P

1 - MiV-PA2 (Minor) - Change of package insert (issue

date : 31 Aug 2016, date of revision : Oct 2017)


Bhd

122 (685)/DRU/DRA.Variation/2018Exjade 125mg Dispersible

TabletsDeferasirox 125mg BRU12110964P


(package insert, new date of revision: July 2018)


Bhd

123 (686)/DRU/DRA.Variation/2018Exjade 500mg Dispersible

TabletsDeferasirox 500mg

1 - MiV-PA2 (Minor) -

Change of product

labelling (package

insert, new date of

revision: July 2018)


(package insert, new date of revision: July 2018)


Bhd

124 (687)/DRU/DRA.Variation/2018 Hydrocort CreamHydrocortisone acetate

10mg/g (1%w/w)BRU14071346P


carton, inner label and package insert)

2 - MiV-PA28 (Minor) (inc MiV-PA30 & MiV-PA31) -

Change /addition in primary packaging material and pack

size for non-sterile product and change of outer carton

pack sizes for drug product

3- MiV-PA24 (Minor) - Change of release and shelf-life


Asterix United (B) Sdn

Bhd

125 (688)/DRU/DRA.Variation/2018Uripax Film-coated Tablet

200mgFlavoxate HCI 200mg BRU13061085P


carton and package insert)


Bhd

126 (689)/DRU/DRA.Variation/2018Hydrocortisone Injection

100mg

Each vial contains

Hydrocortisone Sodium

Succinate BP quivalent to

Hydrocortisone Sodium

Succinate BP equivalent to

Hydrocortisone 100mg

BRU18022309P1 - MiV-PA1 (Minor) - Change of product name to Zycort

Injection 100mg)G&H Trading Company


LAMPIRAN C

127 (690)/DRU/DRA.Variation/2018Esmeron Injection

50mg/5ml (10mg/ml)

Rocuronium Bromide

50mg/5ml

BRU10120613PS1;

BRU10120613PS2


carton, inner label and package insert; new date of

revision; August 2018)


Bhd

128 (691)/DRU/DRA.Variation/2018 Dalacin C 300mg CapsuleClindamycin (as

Hydrochloride) 300mgBRU11020643


package insert (Version: Dalacin C 300-0818, Date of

Revision: 27 August 2018)



substance

3- MiV-N6 (Minor) - Change of the name and address of

a manufacturer of the drug susbtance


Bhd

129 (692)/DRU/DRA.Variation/2018Dalacin C Sterile Solution

150mg/ml x 2ml ampouleClindamycin Phosphate 300mg BRU11110809P


carton and package insert, new date of revision 27

August 2018)

2-MiV-N6 (Minor) - Change of the name and/or address

of a manufacturer of the drug substance


Bhd

130 (693)/DRU/DRA.Variation/2018Tobradex Eye Drops

Suspension

Tobramycin 0.3%;

Dexamethasone 0.1%BRU14081467P

1 - MiV-N6 (Minor)- Change of the name and/or address

of a manufacturer of the drug substance,

dexamethasone



susbtance, dexamethasone


Bhd

131 (694)/DRU/DRA.Variation/2018 Tobradex Eye OintmentTobramycin 0.3%;

Dexamethasone 0.1%BRU14071326P

1 - MiV-N6 (Minor) - Change of the name and/or address


dexamethasone





Bhd

132 (695)/DRU/DRA.Variation/2018Maxidex Sterile Opthalmic

SuspensionDexamethasone 0.1% (img/ml) BRU14071360P



dexamethasone





Bhd

133 (696)/DRU/DRA.Variation/2018 Maxitrol Eye Drops

Per 1ml - Dexamethasone

0.1%; Neomycin Sulphate

3,500IU; Polymyxin B Sulphate

6,000 IU

BRU13081128P



dexamethasone





Bhd

134 (697)/DRU/DRA.Variation/2018 Maxitrol Eye Ointment

Per g : Neomycin Sulfate 3,500

IU; Polymyxin B Sulfate

6,000IU; Dexamethasone 0.1%

BRU1306108P



dexamethasone





Bhd


LAMPIRAN C

135 (698)/DRU/DRA.Variation/2018 Betopic S Eye DropsBetaxolol 2.5mg/ml (as

Hydrochloride 2.8mg)BRU14091504P

1 - MiV-N6 (Minor)- Change of the name and address of

a manufacturer of the drug substance



substance including extension of retest period from 3

years to 5 years


Bhd

136 (699)/DRU/DRA.Variation/2018 Dextramine Tablet 2mg Dexchlorpheniramine 2mg BRU14081448P

1 - MiV-N1 (Minor) including MiV-N2 and MiV-N4 -

Change in the name of the marketing authorisation

holder (including name of product owner and name of

drug product manufacturer)

2 - MiV-PA2 - Change of product labelling (blister label,

outer carton and package insert, new date of revision

May 2016)


137 (700)/DRU/DRA.Variation/2018 A-Bite Cream Crotamiton 10%w/w BRU3091145NP1 - MiV-PA2 (Minor) - Change of outer carton label, inner

label and package insert (Date of revision: May 2013)G&H Trading Company

138 (701)/DRU/DRA.Variation/2018HOE's Milk of Magnesia Oral

Suspension 800mg/5ml

Magnesium Hydroxide

800mg/5mlBRU17082241P

1 - MiV-PA2 (Minor) - Change of label and package insert

(Date of revision:April 2018)G&H Trading Company

139 (702)/DRU/DRA.Variation/2018 Tussils 5 Lozenge 5mgDextromethorphan

Hydrobromide 5mgBRU14071386P

1 - MiV-PA2 (Minor) - Change of Product Information

Leaflet (Date of revision : Mar 2018)


Bhd

140 (703)/DRU/DRA.Variation/2018 Minazol Powder 2% Miconazole Nitrate 2% w/w BRU13081123P

1 - MiV-PA2 (Minor)- Change of inner label and package

insert (Version: PP-M0028-B1-G/00)

2 - MiV-N1 (Minor) including MiV-N2 and MiV-N4 -

Change in name of the marketing authorization holder

including change in product owner and change in name

of manufacturer of drug product


141 (704)/DRU/DRA.Variation/2018 Regpara® Tablets 25mg

Cinacalcet hydrochloride

27.55mg eqv to Cinacalcet

25mg

BRU17112262P

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

package insert (Revised: February 2017, Version: AR25A-

3)

2- MiV-PA11 (Minor) - Change of storage condition for

drug substance

3- MiV-PA15 (Minor) - Qualitative change of excipient


142 (705)/DRU/DRA.Variation/2018Axcel Chlorpheniramine-4

Syrup

Chlorpheniramine Maleate

4mg/5mlBRU14011212P

1 - MiV-PA13 (Minor) - Change of batch size of non-

sterile drug product


specifications including analytical procedure of the drug

product

Medicorp Sdn Bhd

143 (706)/DRU/DRA.Variation/2018 Axcel Dextrozine Syrup

Dextromethorphan

Hydrobromide 15mg/5ml;

Promethazine HCI 3.6mg/5ml

BRU12030883P1 - MiV-PA34 (Minor) - Reduction of shelf-life of the drug

product (to 2 years)Medicorp Sdn Bhd


LAMPIRAN C


Mabthera Concentrate for

Solution for Infusion

100mg/10ml

Rituximab 100mg/10ml

BRU14081432PS1,

BRU14081432PS2 &

BRU14081432PS3


substance

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


3- MiV-PA (Minor) - Minor process changes resulting

from updated virus clearance evaluation

4- MiV-PA (Minor) - Addition of drug substance storage

site

Medipharm Sdn Bhd


Mabthera Concentrate for


500mg/50ml

Rituximab 500mg/50ml

BRU14071397PS1,

BRU14071397PS2 &

BRU14071397PS3


substance



3- MiV-PA (Minor) - Minor process changes resulting

from updated virus clearance evaluation

4- MiV-PA (Minor) - Addition of drug substance storage

site

Medipharm Sdn Bhd

146 (709)/DRU/DRA.Variation/2018Harnal OCAS 400mcg Film-

coated tablet

Tamsulosin (as hydrochloride

400mcg Film-coated tabletBRU10090552P

1 - MiV-PA2 (Minor) - Change of package insert (Date of

approval : August 2018, Version: NCDS 02 (SI) Harnal

OCAS)

Medipharm Sdn Bhd

147 (710)/DRU/DRA.Variation/2018 Vesicare® 5mg Tablet Solifenacin Succinate 5mg BRU11070724P1 - MiV-PA2 (Minor) - Change of package insert (Date of

approval; August 2018, Version : IPI SI03 Vesicare)Medipharm Sdn Bhd

148 (711)/DRU/DRA.Variation/2018 Vesicare 10mg Tablet Solifenacin Succinate 10mg BRU10120609P1 - MiV-PA2 (Minor) - Change of package insert (Date of

approval; August 2018, Version : IPI SI03 Vesicare)Medipharm Sdn Bhd

149 (712)/DRU/DRA.Variation/2018Ciprobay® 200 Infusion

Solution

Ciprofloxacin (as lactate)

200mgBRU08090124P


drug product (Addition of alternative test method)


Bhd

150 (714)/DRU/DRA.Variation/2018Axcel Oxymetazoline

0.025% Nasal Drop

Oxymetazoline hydrochloride

0.025% w/vBRU16052042P



2 - MiV-PA24 (Minor) including MiV-PA27 - Change of

release and shelf-life specifications of drug product

including change in the test procedure of drug product

Medicorp Sdn Bhd

151 (715)/DRU/DRA.Variation/2018 Fucithalmic Eye Drops 1% Fusidic acid 10mg/g BRU17122285P

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



substance



finished product formulation (External lacquer)

LF Asia (Borne) Sdn Bhd


LAMPIRAN C

152 (716)/DRU/DRA.Variation/2018Kogenate FS for Injection

250IU/vial

Antihaemophilic Factor

(recombinant) sucrose

formulated 250IU

BRU12120979P

1- MaV-4 (Major) - Addition of quality control testing site



3- MiV-PA (Minor) - Drug product change in test method -

removal of alternate method

4- MiV-N7 (Minor) - Deletion of alternative manufacturer

of drug product


Bhd


500IU/vial



formulated 500IU

BRU15021752P







of drug product


Bhd


1000IU/vial



formulated 1000IU

BRU15021751P







of drug product


Bhd


LAMPIRAN C

155 (719)/DRU/DRA.Variation/2018 Infanrix Hexa™

Composition of

reconstituitiuted DTPa-HBV-

IPV+Hib Vaccine per dose

(0.5ml) : Diphteria toxoid min

30 I.U; tetanus toxoid min. 40

I.U; Pertusus toxoid (PT) 25µg;

Filamentous haemagglutinin

(FHA), adsorbed 25µg;

Pertactin, adsorbed 8µg; r-

DNA Hepatitis B surface

antigen (HBsAg purified) 10µg;

Inactivated poliomyeltis virus

type I 40 DU, Inactivated

poliomyeltis virus type II 8DU,


type II 8DU; Inactiavted

poliomyeltis virus type III 32

DU; Conjugate of Haemophilus

influenza type b capsular

polysaccharide (PRP) and

tetanus toxoid 10µg PRP and

~25µg T

BRU11090763P1 - MiV-PA27 (Minor) - Change in test procedure of the

drug product


Bhd


LAMPIRAN C

156 (720)/DRU/DRA.Variation/2018Infanrix™-IPV+Hib Vaccine

(DTPa-IPV+Hib)

1 dose (0.5ml) contains;

Diphteria toxoid (DT) Min 3-

I.U.;Tetanus toxoid (TT) Min 40

I.U.; Pertussis toxoid (PT) Min

25mcg; Filamentous

haemagglutinin (FHA) 25mcg;

Pertactin (69 kda Outer

membrance protein) 8mcg;

Inactivated Polio Virus Type 1

(Mahoney seed) 50DU;


(MEF-1 seed) 8DU; Inactivated

Polio Virus Type 3 (Saukett

seed) 34D; Conjugate of

purified capsular

polysaccharide (10mcg) of


covalently bound to

approximately 30mcg to

50mcg tetanus toxoid

BRU12010840P1 - MiV-PA27 (Minor) - Change in test procedure of the

drug product


Bhd

157 (721)/DRU/DRA.Variation/2018Infanrix™-IPV+Hib Vaccine

(DTPa-IPV+Hib)

1 dose (0.5ml) contains;

Diphteria toxoid (DT) Min 3-

I.U.;Tetanus toxoid (TT) Min 40

I.U.; Pertussis toxoid (PT) Min

25mcg; Filamentous

haemagglutinin (FHA) 25mcg;

Pertactin (69 kda Outer

membrance protein) 8mcg;


(Mahoney seed) 50DU;


(MEF-1 seed) 8DU; Inactivated

Polio Virus Type 3 (Saukett

seed) 34D; Conjugate of

purified capsular

polysaccharide (10mcg) of


covalently bound to

approximately 30mcg to

50mcg tetanus toxoid

BRU12010840P

1- MaV-3 (Major) - Addition of alternative manufacturer

of drug substance (where European Pharmacopeial

Certificate of Suitability (CEP) is not available

2- MiV-PA7 (Minor) - Change of manufacturing process of

the drug substance (where European Certificate of

Suitability (CEP) is not available)

3- MiV-PA9 (Minor) - Change of test procedure of non-



Bhd


LAMPIRAN C

158 (722)/DRU/DRA.Variation/2018 Infanrix Hexa™

Composition of

reconstituitiuted DTPa-HBV-

IPV+Hib Vaccine per dose

(0.5ml) : Diphteria toxoid min

30 I.U; tetanus toxoid min. 40

I.U; Pertusus toxoid (PT) 25µg;

Filamentous haemagglutinin

(FHA), adsorbed 25µg;

Pertactin, adsorbed 8µg; r-

DNA Hepatitis B surface

antigen (HBsAg purified) 10µg;


type I 40 DU, Inactivated

poliomyeltis virus type II 8DU,


type III 32 DU; Conjugate of


capsular polysaccharide (PRP)

and tetanus toxoid 10µg PRP

and ~25µg T

BRU11090763P




2 - MaV-6 (Major) - Change of specification drug

substance HBV (where European Pharmacopoeial



of the drug substance TT (where European Certificate of

Suitability (CEP) is nort available


compendial drug substance (IPV) (where European



Bhd

159 (723)/DRU/DRA.Variation/2018 Infanrix™-IPV Vaccine

Composition per dose (0.5ml):

Diptheria toxoid (DT),

adsorbed min.30 I.U; tetanus

toxoid (TT), adsorbed min 40

I.U; Pertusis toxoid (PT),

adsorbed 25µg;Filamentous

haemagglutinin (FHA),

adsorbed 25µg; Pertactin,

adsorbed 8µg;inactivated

poliomyeltis virus type I 40 DU,


type II 8DU, Inactivated


DU

BRU11090766P


of the drug substance, TT (where European Cetificate of


2 - MiV-PA7 (Minor) - CTD update in manufacturing

process and control of materials, IPV (where European


3- MiV-PA9 (Minor) - Change of test procedure of non-

compendial drug substance (IPV)


Bhd

160 (724)/DRU/DRA.Variation/2018Suprefact® 1mg/ml Injection

Solution

Buserelin 1.00mg/ml (as

acetate 1.05mg)BRU10090548P

1 - Mav -9 (Major) including MiV-PA19 (Minor) - Major

change in the manufacturing process for the drug

product including change of in-process controls applied

during the manufacture of the drug product

Medipharm Sdn Bhd


LAMPIRAN C

161 (725)/DRU/DRA.Variation/2018 Coveram 5/10mg Tablet

Perindopril arginine 5mg

(equiv. To 3.395mg

perindopril) and amlodipine

10mg (as besilate 13.870mg)

BRU11070736P


Final_PI_BRU_Coveram27.07.2017, Date of revision:

27.07.2017)


Bhd



(equiv. To 3.395mg

perindopril) and amlodipine

5mg (as besilate 6.935mg)

BRU11050710P



27.07.2017)


Bhd



(equiv. To 6.790mg);

Amlodipine 5mg (as besilate

6.935mg)

BRU11100787P



27.07.2017)


Bhd



(equiv. To 6.790mg);

Amlodipine 10mg (as besilate

13.870mg)

BRU11100791P



27.07.2017)


Bhd

165 (729)/DRU/DRA.Variation/2018 Bilaxten 20mg Tablet Bilastine 20mg BRU16102084P

1 - MiV-PA2 (Minor) - Change of outer carton label and

package insert (Date of revision: January 2018) due to

change in pack from Singapore to Malaysia pack


Bhd


Victoza® 6mg/ml, Solution

for Injection in Pre-filled

Pen

Liraglutide 6mg/ml BRU18062349P

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

indication of the product including change in package

insert (Date of revision: 2018)

2 - MiV-PA2 (Minor) - Change in inner label and outer

carton


Bhd

167 (731/DRU/DRA.Variation/2018Torisel Concentrate for

Injection 25mg/mlTemsirolimus 25mg/ml BRU15011725P

1 - MiV-PA2 (Minor) - Change in package insert (Version :

TORISEL-0618, Date of revision: 21 June 2018)


Bhd

168 (732/DRU/DRA.Variation/2018Sutent™ Hard Capsules

12.5mgSunitinib 12.5mg (as Malate) BRU12120974P

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

indication of the product including change in package

insert (Version: SUTENT-0218, Date of revision: 23 Feb

2018


Bhd

169 (733)/DRU/DRA.Variation/2018Xeljanz Film-Coated Tablet

5mgTofacitinib (as citrate) 5mg BRU17082232P

1- MiV-PA2 (Minor) - Change in package insert

(Version:XELJANZ-1218, date of revision: 06 Dec 2018)


Bhd

170 (734)/DRU/DRA.Variation/2018Proglutrol 500 Extended

Release Tablets

Metformin Hydrochloride

500mgBRU15071905P

MiV-PA2 (Minor)- Change of product labelling (blister

label, outer carton and package insert, new date of

revision Dec 2017)

Medicorp Sdn Bhd

171 (735)/DRU/DRA.Variation/2018Axcel Clindamycin Topical

Soultion 1% w/vClindamycin Phosphate 1% BRU18062350P


product (to 2 years)Medicorp Sdn Bhd

172 (736)/DRU/DRA.Variation/2018Adrenalin (Epinephrine)

Injection 1:1000

Adrenalin (Epinephrine) as

acid tartrateBRU16092073P


(package insert; new date of revision 03/2018)Medicorp Sdn Bhd

173 (737)/DRU/DRA.Variation/2018 Coxan Tablets 500mg Paracetamol 500mg BRU1601196NP1 - MiV-PA2 (Minor)- Change in product labelling (outer

carton and package insert)Medicorp Sdn Bhd


LAMPIRAN C

174 (738)/DRU/DRA.Variation/2018 Virless Tablets 200mg Acyclovir 200mg BRU11010642P


carton and package insert; new date of revision : 03 Aug

2017)


Bhd

175 (739)/DRU/DRA.Variation/2018 Prednisolone Tablet 5mg Prednisolone 5mg BRU11110814P

1 - MiV-PA17 (Minor) - Deletion of the colouring agent of

the product

2 - MiV-PA1 (Minor) (inc MiV-PA2) - Change of drug

product name (to YSP Prednisolone 5mg Tablet) with

consequential change in product labelling (outer carton,

inner label and package insert (new date of revision : 07

Mar 2017)

3 - MiV-N10 (Minor)- Deletion of pack size for a product


Bhd

176 (740)/DRU/DRA.Variation/2018 Frotin Pessaries Metronidazole 250mg BRU10120606P

1 - MiV-PA2 (Minor) - Change of product labelling (inner

label, outer carton and package insert; date of revision :

17 Jan 2018


Bhd

177 (741)/DRU/DRA.Variation/2018 Infanrix-IPV Vaccine

Composition per dose (0.5ml):

Diptheria toxoid (DT),

adsorbed min.30 I.U; tetanus

toxoid (TT), adsorbed min 40

I.U; Pertusis toxoid (PT),

adsorbed 25µg;Filamentous

haemagglutinin (FHA),

adsorbed 25µg; Pertactin,

adsorbed 8µg;inactivated

poliomyeltis virus type I 40 DU,


type II 8DU, Inactivated


DU

BRU11090766P1 - MiV-PA (Minor) - Change of analytical procedures of

Drug Product


Bhd

178 (742)/DRU/DRA.Variation/2018Volibris 5mg Film-coated

tabletAmbrisentan 5mg BRU14031258P

1 - Mav-15 (Major) - Extension of shelf-life of the drug



Bhd

179 (743)/DRU/DRA.Variation/2018Volibris 10mg Film-coated

TabletAmbrisentan 10mg BRU14031259P

1 - Mav-15 (Major)- Extension of shelf-life of the drug



Bhd

180 (745)/DRU/DRA.Variation/2018 Synflorix Vaccine

1 dose (0.5ml) contains; 1mcg

of pneumococcal

polysaccharide serotypes 1,5,

6B, 7F, (V, 14, 23F; 3mcg of

pneumococcal polysaccharide

serotypes 4, 18C and 19F

BRU11120819P0.5gV &

BRU11120819p0.5gS

1 - MiV-PA8 (Minor)- Change of the specification of drug

substance


Bhd

181 (747)/DRU/DRA.Variation/2018 Senokot Tablet Sennoside B 7.5mg BRU17012136NP

1 - MiV-PA2 (Minor) - Change in Outer Carton label and

patient information leaflet (date of revision :

07/04/2017)


Bhd


LAMPIRAN C




revision : 07 May 2019)

2 - MiV-PA (Minor) - Changes to specification and test

procedure of raw material - Isopropylmagnesium

chloride/Lithium chloride in tetrahydrofuran in the

synthesis of empagliflozin


Bhd




revision : 07 May 2019)

2 - MiV-PA (Minor) - Changes to specification and test

procedure of raw material - Isopropylmagnesium

chloride/Lithium chloride in tetrahydrofuran in the

synthesis of empagliflozin


Bhd

184 (752)/DRU/DRA.Variation/2018 Melashine Cream 4% Hydroquinone 40mg/g BRU14071408P 1 - MiV-PA14 (Minor) - Removal of overageAsterix United (B) Sdn

Bhd

185 (753)/DRU/DRA.Variation/2018 Ucort CreamPer g - Urea 100mg;

Hydrocortisone acretate 10mgBRU13121168P

1 - MiV-PA28 (Minor) - Inclusion of primary package

material for non-sterile product with consequential

addition of pack size

2 - MiV-N9 (Minor) - Change of release and shelf-life

specifications of drug product following the updates in

compendium


BHd

186 (754)/DRU/DRA.Variation/2018 Vastarel 20mg TabletTrimetazidine dihydrochloride

20mgBRU09050249P

1 - MiV-PA2 (Minor) - Change in package insert (Version ;

Final_PI_BRU_Vastarel 20mg_15.02.2018, Date of

revision : 15.02.2018)


Bhd

187 (755)/DRU/DRA.Variation/2018 Coversyl Plus TabletPerindopril tert-butylamine

4mg, Indapamide 1.25mgBRU09050250P

1 - MiV-PA2 (Minor) - Change in package insert (Version ;

Final_PI_BRU_Coversyl_Plus_4mg_26.09.2017, Date of

revision : 26.09.2017)


Bhd

188 (756)/DRU/DRA.Variation/2018 Lyrica Capsules 50mg Pregabalin 50mg BRU12100949P


substance

2 - MiV-N7 (Minor) - Deletion of the alternative

manufacturer (for drug subtance:pregabalin)


Bhd

189 (757)/DRU/DRA.Variation/2018 Lyrica™ 75mg Capsules Pregabalin 75mg BRU12060909P


substance




Bhd

190 (758)/DRU/DRA.Variation/2018 Lyrica™ 150mg Capsules Pregabalin 150mg BRU12020870P


substance




Bhd

191 (760)/DRU/DRA.Variation/2018 Afinitor Tablet 2.5mg Everolimus 2.5mg BRU14091507P 1 - MiV-PA (Minor) - Update of Stability reportZuellig Pharma (B) Sdn

Bhd

192 (761)/DRU/DRA.Variation/2018 Afinitor Tablet 5mg Everolimus 5mg BRU14091519P 1 - MiV-PA (Minor) - Update of Stability reportZuellig Pharma (B) Sdn

Bhd

193 (762)/DRU/DRA.Variation/2018 Afinitor Tablet 10mg Everolimus 10mg BRU13021012P 1 - MiV-PA (Minor) - Update of Stability reportZuellig Pharma (B) Sdn

Bhd


LAMPIRAN C


Remicade Powder for

Concentrate for Solution for

Infusion 100mg/vial

Infliximab (cA2 IgG) 100

mg/vialBRU10050468P

1 - MiV-PA (Minor) -Change in Inner label, outer carton

label and package insert (Date of revision : 26 December

2018 (Based on EU SmPC dated April 2018))


Bhd

195 (766)/DRU/DRA.Variation/2018Axcel Lamivudine 100mg

TabletLamivudine 100mg BRU16082064P

1 - MaV-15 (Major) - Extension of Shelf life of Drug

Product (to 4 years)Medicorp Sdn Bhd

196 (768)/DRU/DRA.Variation/2018 Travocort Cream

Isoconazole nitrate (10mg/g) :

Diflucortolone valerate

(1mg/1g)

BRU18012290P1 - MiV-PA19 (Minor) - Change of in-process controls



Bhd

197 (770)/DRU/DRA.Variation/2018 Synflorix™ Vaccine

1 dose (0.5ml) contains :

Pneumococcal polysaccharide

serotype 1¹¸²-1mcg,


serotype 4¹¸² - 3mcg,


serotype 5¹´²- 1mcg,


serotype 6B¹´²-1mcg,


serotype 7F¹´²-1mcg,


serotype 9V¹´²-1mcg,


serotype 14¹´²-1mcg,


serotype 18C¹´³-3mcg,


serotype 19F¹´⁴-3mcg,


seotype 23F¹´²-1mcg

Note: ¹adsorbed on aluminium

phosphate - 0.5mg AI³+;²

conjugated to protein D

9derived from non-typeable

Haemophilus influenza) carrier

protein - 9-16mcg;³ conjugated

to tetanus toxoid carrier

protein - 5-10mcg ;

⁴conjugated to diphtheria

toxoid carrier protein - 3-6mcg

BRU11120819P0.5gV &

BRU11120819P0.5gSP


the drug product


Bhd

198 (558)/DRU/DRA.Variation/2019 UO Cream 100mg/g (10%)Carbonyldiamide (Urea)

100mg/g (10%)BRU17012143NP

1- MiV-PA2 (Minor) - Change of product labelling (inner

label, outer carton and package insert)


Bhd


LAMPIRAN C


1 (932)/DRU/DRA.Variation/2017 Norvasc Tablet 5mg Amlodipine Besylate BRU10060494P 1 - MiV-PA2 (Minor) - Change of package insert (Date of

revision: 01 JUN 2018; LPD Date : 03 June 2018 (CDS

ver.11 dated 10 March 2017) and product labelling (outer

carton and blister label)

2 - MaV-4 (Major) - Replacement of manufacturing site of

the drug product

3 - MaV-5 (Major) - Replacement of manufacturing site

for the primary packaging (direct contact with drug

product)

4 - MiV-PA34 (Minor) - Reduction of shelf-life of drug

product



storage condition)


Bhd

2 (933)/DRU/DRA.Variation/2017 Norvasc Tablet 10mg Amlodipine Besylate BRU10070508P 1 - MiV-PA2 (Minor) - Change of package insert (Date of

revision: 01 JUN 2018; LPD Date : 03 June 2018 (CDS

ver.11 dated 10 March 2017) and product labelling (outer

carton and blister label)

2 - MaV-4 (Major) - Replacement of manufacturing site of

the drug product

3 - MaV-5 (Major) - Replacement of manufacturing site

for the primary packaging (direct contact with drug

product)

4 - MiV-PA34 (Minor) - Reduction of shelf-life of drug

product



storage condition)


Bhd

3 (382)/DRU/DRA.Variation/2018 Orgalutron 0.25mg/0.5ml

Solution for Injection

Ganirelix acetate

0.25mg/0.5ml Solution for

Injection

BRU10120602P 1- MiV-PA2 (Minor) - Change in product labelling (Outer

carton and package insert; updated DATE OF REVISION

OF TEXT: April 2018)


Bhd

4 (501)/DRU/DRA.Variation/2018 Hovasc Tablet 10mg Amlodipine 10mg (as Besylate

13.8mg)

BRU11120834P 1 - MiV-PA15 (Minor) - Qualitative or quantitative change

of excipient



G&H Trading Company

140th DRC Meeting (70 Applications)


LAMPIRAN C

5 (503)/DRU/DRA.Variation/2018 Hovasc Tablet 5mg Amlodipine 5mg (as Besylate

6.90mg)

BRU11090778P 1 - MiV-PA2 (Minor) - Change of product labelling (outer

carton)

2 - MiV-PA15 (Minor) - Qualitative change of excipient

3 - MiV-PA20 (Minor) - Minro change of the


G&H Trading Company

6 (614)/DRU/DRA.Variation/2018 Iressa™ Tablet 250mg Gefitinib 250mg BRU10120617P 1 - MaV-4 (Major) including MiV-PA13 and MiV-PA20 -

Replacement of the manufacturing site of the drug

product with consequential minor change of

manufacturing process for non-sterile product and

change of batch size of non-sterile drug product


the drug product

3 - MiV-N6 (Minor) - Change of name and address of a

manufacturer of drug substance


Bhd

7 (746)/DRU/DRA.Variation/2018 Synflorix™ Vaccine 1 dose (0.5ml) contains:


1¹´²- 1mcg, Pneumococcal

polysaccharide serotype 4¹´²-

3mcg, Pneumococcal


1mcg, Pneumococcal

polysaccharide serotype 6B¹´²-

1mcg, Pneumococcal

polysaccharide serotype 7F¹´²-

1mcg, Pneumococcal

polysaccharide serotype 9V¹´²-

1mcg, Pneumococcal


1mcg, Pneumococcal

polysaccharide serotype 18C¹´³-

3mcg, Pneumococcal

polysaccharide serotupe 19F¹´⁴-

3mcg, Pneumococcal

polysaccharide serotype 23F¹´²-

1mcg.

Note : ¹adsorbed on aluminium

phosphate - 0.5mg Al³⁺;²


(derived from non-typeable


protein -9-16mcg;³ conjugated

to tetanus toxoid carrier

protein -5-10mcg;⁴conjugated

to diptheria toxoid carrier

protein -3-6mcg

BRU11120819P0.5gV &

BRU11120819P0.5gS

1 - MiV-PA (minor) - Update of CTD dossier Zuellig Pharma (B) Sdn

Bhd


LAMPIRAN C

8 (759)/DRU/DRA.Variation/2018 Stelara Solution for Injection

in pre-filled syringe

45mg/0.5ml

Ustekinumab 45mg/0.5ml BRU12120975PS1;

BRU12120975PS2

1 - MaV-15 (Major) - Extension of Shelf life of Drug

Product





3 - MiV-PA (Minor) - Addition of new working cell bank


Bhd

9 (764)/DRU/DRA.Variation/2018 Tarceva Tablet 100mg Erlotinib 100mg BRU17012130PS2 1 - MiV-PA2 (Minor) - Change in package insert

(Reference number: TAB-TAR-2018 06-0, Date of

revision:Jun 2018)

2 - MiV-PA3 (Minor) including MiV-N5 - Replacement of

the company or party responsible for batch release

including change of address of the manufacturer

responsible for batch release



4 - MiV-N4 (Minor) with consequential MiV-PA2 - Change

of name of the manufacturer of drug product with

consequential change in label artwork (outer carton)

Hongkiat Trading &

Company

10 (765)/DRU/DRA.Variation/2018 Tarceva Tablet 150mg Erlotinib 150mg BRU17012131PS2 1 - MiV-PA2 (Minor) - Change in package insert

(Reference number: TAB-TAR-2018 06-0, Date of

revision:Jun 2018)

2 - MiV-PA3 (Minor) including MiV-N5 - Replacement of

the company or party responsible for batch release

including change of address of the manufacturer

responsible for batch release



4 - MiV-N4 (Minor) with consequential MiV-PA2 - Change

of name of the manufacturer of drug product with

consequential change in label artwork (outer carton)

Hongkiat Trading &

Company

11 (767)/DRU/DRA.Variation/2018 Axcel Cefaclor-500 Capsule Cefaclor 500mg (as

monohydrate)

BRU14071334P 1 - MaV-6 (Major) inlcuding MiV-PA24 and MiV-PA27 -

Change of specification of drug product (where European

Pharmacopoeial certificate of suitability (CEP) is not

available) including change of release and shelf-life

specifications of the drug product and change in the test

procedure of the drug product


product

Medicorp Sdn Bhd


LAMPIRAN C

12 (769)/DRU/DRA.Variation/2018 Avodart Soft Capsules

0.5mg

Dutateride 0.5mg BRU11030672P 1 - MiV-PA2 (Minor) - Change in blister label, outer

carton and package insert (Version Number : v01,

reference: GDS20/IPI17 and UK SPC 17 Nov 2017, Date of

local revision : 24 Sep 2018)


Bhd

13 (771)/DRU/DRA.Variation/2018 Havrix™ 720 Junior Vaccine Inactivated Hepatitis A virus


720 EL.U

BRU11010638P 1 - MiV-PA9 (Minor) - Change of test procedure of non-

compendial drug substance (inactivated hepatitis A virus)


Bhd

14 (772)/DRU/DRA.Variation/2018 Havrix™ 720 Junior Vaccine Inactivated Hepatitis A virus


720 EL.U

BRU11010638P 1 - MiV-PA (Minor) - Update of CTD dossier for section

P5.2


Bhd

15 (773)/DRU/DRA.Variation/2018 Havrix 1440 Vaccine Inactivated Hepatitis A virus

antigen (HAV0, HM175 starin

1440 ELISA Units (EL.U.)/ml

BRU14021215P 1 - MiV-PA9 (Minor) - Change of the test procedure of

non-compendial drug substance (Inactivated hepatitis A

virus)


Bhd

16 (774)/DRU/DRA.Variation/2018 Twinrix™ Vaccine Hepatitis A virus antigen 720

ELISA units; r-DNA hepatitis B

virus surface antigen

(HBsAg)*20µg *Thiomersal-

free HBsAg purified bulk

BRU11080752P 1 - MiV-PA27 (Minor) - Change in the test procedure of

the drug product


Bhd

17 (775)/DRU/DRA.Variation/2018 Twinrix™ Vaccine Hepatitis A virus antigen 720

ELISA units; r-DNA hepatitis B

virus surface antigen

(HBsAg)*20µg *Thiomersal-

free HBsAg purified bulk

BRU11080752P 1 - MiV-PA7 (Minor) - Change of manufacturing process

of the drug substance, Hepatitis B antigen (where

European Pharmacopoeial Certificate of Suitability (CEP)

is not available ) - Administrative changes only


compendial drug substance, inactivated hepatitis A virus


Bhd

18 (776)/DRU/DRA.Variation/2018 Engerix™-B Adult Dose

Vaccine 20mcg/ml

Purified Hepatitis B Surface

Antigen (HBsAg) 20mcg/ml

BRU11010637P 1 - MiV-PA7 (Minor) - Change of manufacturing process

of the drug substance (where European Pharmacopoeial

Certificate of Suitability (CEP) is not available ) -

Administrative changes only


Bhd

19 (777)/DRU/DRA.Variation/2018 Engerix™-B Paediatric

Vaccine 10mcg/0.5ml

Purified HBs-Ag 10mcg BRU11040690P 1 - MiV-PA7 (Minor) - Change of manufacturing process

of the drug substance (where European Pharmacopoeial

Certificate of Suitability (CEP) is not available ) -

Administrative changes only


Bhd

20 (778)/DRU/DRA.Variation/2018 Primovists 0.25mmol/ml

solution for injection

Gadoxetic acid, Sodium

0.25mmol/ml

BRU14111638P 1 - MiV-PA5 (Minor) - Change of batch size of drug

substance (where European Pharmacopoeial Certificate

of Suitability (CEP) is not available)


of the drug substance (where European Pharmocopoeial


3 - MiV-PA8 (Minor)- Change of specification of drug

substance


Bhd


LAMPIRAN C

21 (779)/DRU/DRA.Variation/2018 Gastografin Solution 1ml contains Sodium

amidotrizoate 0.1g and

Meglumine amidotrizoate

0.66g

BRU16011990P 1 - MiV-PA13 (Minor) - Change of batch size of non-




3 - MiV-N9 (Minor) - Editorial change of specifications of

excipient following updates in the compendium

4 - MiV-PA10 (Minor) - Correction of re-test period for

drug substance

5 - MiV-PA (Minor) - Editorial change in manufacturing

process


Bhd

22 (780)/DRU/DRA.Variation/2018 Acular Ophthalmic Solution

0.5%

Ketorolac Tromethamine 0.5% BRU15091928P 1 - MaV-6 (Major) - Change of the Shelf-life specification

drug product (where European Pharmacopoeial


2 - MiV-PA2 (Minor) - Change in inner label, outer carton

and package insert (Revision Date : April 2018)


the drug product (increasing from current approved

storage condition)

Medipharm Sdn Bhd

23 (781)/DRU/DRA.Variation/2018 Telfast-D Extended Release

Tablet

Fexofenadine hydrochloride

60mg ; Pseudoephedrine HCI

120mg

BRU10080535PS2 1 - MiV-PA2 (Minor) - Change of inner label, outer carton

and package insert (ID number : PI Telfast D Bulk

Compiegne-SG-1 / 543626, Version number: 3, Date of

Revision : Jan 2018 (Based on USPI June 2006))

Medipharm Sdn Bhd

24 (783)/DRU/DRA.Variation/2018 Primodil 5 Tablet Amlodipine Besilate 6.94mg

(equivalent to Amlodipine

5mg)

BRU16032021P 1 - MiV-PA25 (Minor) including MiV-PA2- Change of

imprints, bossing or other markings on the tablets,

including change in package Insert (Date of revision ; 14

May 2009)

Medicorp Sdn Bhd

25 (784)/DRU/DRA.Variation/2018 Vaxcel Cefuroxime 750mg

Injection

Cefuroxime (as sodium) 750mg BRU08080115P 1 - MiV-PA35 (Minor), including MiV-PA2 - Change of

storage conditions of the drug product (increasing from

the current approved storage condition), including

change in product labelling (inner label, outer carton and

Package insert, Version : PMSPAVXC01000-090517 (03))

Medicorp Sdn Bhd

26 (785)/DRU/DRA.Variation/2018 Axcel Chlorpheniramine-2

Syrup

Chlorpheniramine-2 Syrup BRU14111651P 1 - MiV-PA13 (Minor) - Change of batch size of non-


Medicorp Sdn Bhd

27 (786)/DRU/DRA.Variation/2018 Pred Forte Sterile

Ophthalmic Suspension 1%

Prenisolone acetate 1% w/v BRU15101956P 1 - MiV-PA2 (Minor) - Change of inner label, outer carton

and package insert (Date of Revision:March 2018)

Medipharm Sdn Bhd


LAMPIRAN C

28 (787)/DRU/DRA.Variation/2018 Targocid® Injection 200mg Teicoplanin 200mg/3ml

(200mg/vial)

BRU12010857P 1 - MiV-N4 (Minor) including MiV-PA2 - Change of name

of manufacturer of drug product including change of

inner label, outer carton and package insert (date of

revision: April 2018/CCDS v1)



storage condition)

Medipharm Sdn Bhd

29 (788)/DRU/DRA.Variation/2018 Eloxatin 5mg/ml


Infusion (10ml)

Oxaliplatin 50mg/10ml BRU11090764P 1 - MaV-6 (Major) - Change of the specification of the



2 - MiV-PA12 (Minor) - Revision and deletion of


of drug substance

Medipharm Sdn Bhd

30 (789)/DRU/DRA.Variation/2018 Eloxatin 5mg/ml


Infusion (20ml)

Oxaliplatin 50mg/20ml BRU11090765P 1 - MaV-6 (Major) - Change of the specification of the



2 - MiV-PA12 (Minor) - Revision and deletion of


of drug substance

Medipharm Sdn Bhd

31 (793)/DRU/DRA.Variation/2018 Creobic Cream Clotrimazole 1%w/w BRU14081450P 1 - MiV-PA24 (Minor) including MiV-PA27 - Change of

release and shelf-life specifications of the drug product

including change in test procedure of the drug product

2- MiV-PA35 (Minor) - Change of storage condition of


storage condition

Yuh Hua Trading

Company

32 (794)/DRU/DRA.Variation/2018 Neulastim Pre-filled Syringe

6mg/0.6ml

Pegfilgrastim 6mg/0.6ml BRU15021766P 1 - MiV-PA2 (Minor) - Change of package insert

(Version:SGNLAPI01, Date of revision: May 2018)

Medipharm Sdn Bhd

33 (795)/DRU/DRA.Variation/2018 Neupogen Pre-Filled Syringe

30MU/0.5ml

Filgrastim 30mu/0.5ml BRU14011209P 1 - MiV-PA2 (Minor) - Change of package insert

(Version:SGNEUPI02, Date of revision: August 2018)

Medipharm Sdn Bhd

34 (796)/DRU/DRA.Variation/2018 Stilnox 10mg film-coated Zolpidem tartrate 10mg BRU10060496P 1 - MiV-PA2 (Minor) - Change of package insert (Date of

revision:July 2018 (Based on CCDS 14 / France SmPC

dated June 2018))

Medipharm Sdn Bhd

35 (797)/DRU/DRA.Variation/2018 Jevtana® 60mg Concentrate

and Solvent for Solution for

Infusion

Cabazitaxel 60mg/1.5ml BRU12040885P 1 - MiV-PA9 (Minor) - Change of the test procedure of


Medipharm Sdn Bhd

36 (798)/DRU/DRA.Variation/2018 Anikef Sterile 750mg Cefuroxime 750mg BRU08020016P 1 - MiV-PA2 (Minor) - Change in package insert (Revision

Date: 23.10.2017)

Hongkiat Trading &

Company


LAMPIRAN C

37 (799)/DRU/DRA.Variation/2018 Tempol Tablet 500mg Paracetamol 500mg BRU15031818NP 1 - MaV-1 (Major) including MiV-PA2 - Addition of

dosage regimen and change in blister label, outer carton

label and package insert




product



storage condition)

Hongkiat Trading &

Company

38 (807)/DRU/DRA.Variation/2018 Tykerb tablets 250mg Lapatinib 250mg (as ditosylate

monohydrate)

BRU14021233P 1 - MaV-15 (Major) - Extension of shelf-life of the drug

product


Bhd

39 (808)/DRU/DRA.Variation/2018 Afinitor 2.5mg Tablet Everolimus 2.5mg BRU14091507P 1 - MaV-1 (Major) (including MiV-PA2) - Change and/or

additional indication and inclusion of clinical information

extending the usage of the product, including change in

paclage insert (date of revision : Aug 2018)


Bhd

40 (809)/DRU/DRA.Variation/2018 Afinitor 5mg Tablet Everolimus 5mg BRU14091519P 1 - MaV-1 (Major) (including MiV-PA2) - Change and/or





Bhd

41 (810)/DRU/DRA.Variation/2018 Afinitor 10mg Tablet Everolimus 10mg BRU13021012P 1 - MaV-1 (Major) (including MiV-PA2) - Change and/or





Bhd

42 (811)/DRU/DRA.Variation/2018 Diamicron MR 60mg Tablet Gliclazide 60mg BRU11070738PS1 ;

BRU11070738PS2

1 - MiV-PA2 (Minor)- Change of content of product

labelling (package insert, new date of revision :

27.04.2017)


Bhd


Tablet



120mg

BRU10080535PS2 1 - MiV-PA12 (Minor) - Revision of European


substance

Medipharm Sdn Bhd

44 (818)/DRU/DRA.Variation/2018 Unocef Injection 500mg

(Vial)

Ceftriaxone (as Sodium)

500mg

BRU08050060P 1 - MiV-PA35 (Minor) - Change of storage conditions of


storage condition)

Hongkiat Trading &

Company

45 (822)/DRU/DRA.Variation/2018 Davmorid film-coated

Tablet

Diosmin 450mg; Hesperidin

50mg

BRU14111604NP 1 - MiV-PA2 (Minor) - Change of product labelling (blister



BHd

46 (823)/DRU/DRA.Variation/2018 Brozil Film cotaed Tablet

600mg

Gemfibrozil 600mg BRU14111621P 1 - MiV-PA2 (Minor)- Change of product labelling (blister



BHd

47 (824)/DRU/DRA.Variation/2018 Tren Capsules 250mg Tranexamic Acid 250mg BRU14071345P 1 - MiV-PA14 (Minor)- Removal of overage




BHd

48 (825)/DRU/DRA.Variation/2018 Yucomy cream Ketoconazole 20g/g BRU14091501P 1 - MiV-PA14 (Minor) - Removal of overage




BHd


LAMPIRAN C

49 (826)/DRU/DRA.Variation/2018 Vivaxim Suspension and

Solution for Suspension for

Injection

Inactivated Hepatitis A Virus,

GBM Strain¹´²……………….160³

antigen units

¹produced in mRC-5 Human

Diploid Cells

²adsorbed on hydrated

aluminium hydroxide (0.3

milligrams of Al)

³in the absence of an

international standardized

reference, the antigen content

is expressed using an in-house

reference Vi Capsular

Polysachharide of Salmonella

Typhi (Ty2 Strain)...25mcg

BRU11030668P 1 - MiV-PA19 (Minor)- Change of in-process controls


(including tightening and addition of new in-process test)


Bhd

50 (827)/DRU/DRA.Variation/2018 Pentaxim Vaccine Composition of final container











10µg

BRU11080747PS1,

BRU11080747PS2,

BRU11080747PS3

1 - MiV-PA27 (Minor)- Change in the test procedure of

the drug product (including replacement or addition of a

test procedure)


Bhd

51 (841)/DRU/DRA.Variation/2018 Sevoflurane Inhalation

Anaesthetic Liquid 100%

Sevoflurane 100% (1ml/ml) BRU12070928P 1 - MaV-6 (Major)- Change of the specification of drug

substance and/or drug product (where European

Pharmacopoeial Certificate of Suitability (CEP) is not

available)


Bhd

52 (842)/DRU/DRA.Variation/2018 Acular Opthalmic Solution

0.5%

Ketorolac Tromethamine 0.5% BRU15091928P 1 - MaV-6 (Major) - Change of the specification drug

product where (CEP) is not available.

Medipharm Sdn Bhd

53 (843)/DRU/DRA.Variation/2018 Clexane 2000 anti-XA

IU/0.2ml (Pre-filled Syringe

for Injection)

Enoxaparin Sodium 2,000 anti-

Xa IU/0.2ml

BRU13101153P 1 - MiV-PA7 (Minor)- Change of manufacturing process of


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


3 - MiV-PA10 (Minor)- Change of shelf-life or retest

period for drug substance

Medipharm Sdn Bhd


LAMPIRAN C

54 (844)/DRU/DRA.Variation/2018 Clexane 4000/0.4ml anti-XA

Pre-filled Syringe


Xa IU/0.4ml equivalent to

40mg/0.4ml





3 - MiV-PA10 (Minor)- Change of shelf-life or retest


Medipharm Sdn Bhd

55 (845)/DRU/DRA.Variation/2018 Clexane 6000/0.6ml anti-XA

IU Pre-filled Syringe


Xa IU/0.6ml equivalent to

60mg/0.6ml



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


3 - MiV-PA10 (Minor) - Change of shelf-life or retest


Medipharm Sdn Bhd

56 (846)/DRU/DRA.Variation/2018 Calamine Lotion BP 15% wv Calamine 15w/v; Zinc Oxide

5% w/v

BRU17122286NP 1 - MiV-PA1 (Minor)- Change of drug product name to

'SM Calamine Lotion'

2 - MiV-P35 (Minor)- Change of storage conditions of the

drug product (increasing from the current approved

storage condition), with consequential update in product

labelling and package insert dated 26.04.2018

G&H Trading Company

57 (847)/DRU/DRA.Variation/2018 Atropine Sulphate 1mg/1ml

Injection

Atropine Sulphate 1mg/ml BRU14071348P 1 - MaV-1 (Major)- Change of additional dosing regimen

of clinical information extending the usage of the

product

2 -MiV-PA1 (Minor)- Change of drug product name to

'Pharmaniaga Atropine Sulphate 1mg/ml'

3 - MiV-PA2 (Minor)- Change of product labelling (outer

carton, inner label and package insert, new revision date

: 27 Dec 2017)

G&H Trading Company

58 (848)/DRU/DRA.Variation/2018 Lidocaine Hydrochloride 2%

w/v Injection

Lidocaine Hydrochloride 2%

w/v (200mg/10ml

BRU17032174P 1 - MiV-PA1 (Minor)- Change of drug product name to

'Pharmaniaga Lidocaine Hydrochloride 2% w/v Injection'

2 -MiV-PA2 (Minor)- Change of product labelling (outer

carton, inner label and package insert, new date of

revision : 04th December 2015)

G&H Trading Company

59 (849)/DRU/DRA.Variation/2018 Potassium Chloride 10% w/v

Injection

Potassium Chloride 10% w/v BRU16011989P 1 - MiV-PA1 (Minor)- Change of drug product name to

'Pharmaniaga Potassium Chloride 10% w/v Injection'

2 -MiV-PA2 (Minor) - Change of product labelling (outer

carton, inner label and package insert, new date of

revision : 18 September 2017)

G&H Trading Company


LAMPIRAN C

60 (850)/DRU/DRA.Variation/2018 Sodium Bicarbonate 8.4%

w/v Injection (10ml glass

ampoule)

Sodium Bicarbonate 8.4% w/v

(84mg/ml)

BRU14111607NP 1 - MiV-PA1 (Minor)- Change of drug product name to

'Pharmaniaga Sodium Bicarbonate 8.4% w/v Injection'

2 -MaV-2 (Major) (including MiV-PA2) - Change of

product labelling (outer carton, inner label and package

insert, new date of revision : 14 March 2018)

G&H Trading Company

61 (851)/DRU/DRA.Variation/2018 Flebogamma® 5% DIF

Solution for Infusion (50ml)

Human Normal

Immunoglobulin 2.5g/50ml

(50mg/ml)

BRU12010844P 1 - MiV-PA32 (Minor)- Change in any part of the


finished product formulation (such as colour of flip-off

caps, colour code rings on ampoules, change of eedle

shield (different plastic used)

Hongkiat Trading &

Company

62 (852)/DRU/DRA.Variation/2018 Flebogamma 5% DIF


(100ml)

Human Normal

Immunoglobulin 50ml

(50mg/ml)






Hongkiat Trading &

Company

63 (853)/DRU/DRA.Variation/2018 Flebogamma® 5% DIF


(200ml)

Human Normal

Immunoglobulin 10g/200mL

(50mg/ml)






Hongkiat Trading &

Company

64 (854)/DRU/DRA.Variation/2018 Saizen Liquid 12mg

(8mg/ml)

Somatropin 12mg/1.5ml

(recombinant human growth

hormone)

BRU15031825P 1 - MiV-PA13 (Minor)- Change of batch size of non-sterile

drug product

G&H Trading Company

65 (855)/DRU/DRA.Variation/2018 Aprovel 150mg Tablet Irbesartan 150mg BRU08110151P 1 - MiV-PA2 (Minor)- Change of product labelling (inner

label and outer carton)

Medipharm Sdn Bhd

66 (856)/DRU/DRA.Variation/2018 Aprovel 300mg Tablet Irbesartan 300mg BRU08070097P 1 - MiV-PA2 (Minor)- Change of product labelling (inner

label and outer carton)

Medipharm Sdn Bhd

67 (869)/DRU/DRA.Variation/2018 Saizen Liquid 6mg

(5.83mg/ml)

Somatropin 6mg/1.0.3ml

(recombinant human growth

hormone)

BRU15031826P 1 - MiV-PA13 (Minor)- change of batch size of non-sterile

drug product

G&H Trading Company

68 (870)/DRU/DRA.Variation/2018 Motilium Suspension

1mg/ml

Domperidone 1mg/ml BRU14031267P 1 - MiV-PA30 (Minor) - Addition of pack size for non-

sterile product


Bhd

69 (649)/DRU/DRA.Variation/2019 Presolin 300mg tablet Irbesartan 300mg BRU15021773P 1 - MaV-3 (Major)- Addition of alternative manufacturer of drug substance, where CEP is not availableK-Seri Pharma Sdn Bhd


LAMPIRAN C

70 (651)/DRU/DRA.Variation/2019 Presolin 150mg tablet Irbesartan 150mg BRU15021772P 1 - MaV-3 (Major) - Addition of alternative manufacturer of drug substance, where CEP is not availableK-Seri Pharma Sdn Bhd


1 (515)/DRU/DRA.Variation/2018 Axcel Cetirizine Syrup Cetirizine Dihydrochloride

5mg/5ml


sterile drug substance


specification of the drug product

Medicorp Sdn Bhd

2 (574)/DRU/DRA.Variation/2018 Lucentis 10mg/ml Solution

for Injection

Ranibizumab 10mg/ml BRU14071375P 1 - MiV-PA32 (Minor) - Change in sterilisation method for

filter needle

2 - MiV-PA8 (inc MiV-PA19) - Change of the specification

of drug substance a) Specification limits are tigtened b)

Addition of new test parameter and limits

3) MiV-PA11 (Minor) - Change of storage condition for

drug substance

4 - MiV-PA - Introduction of a new primary reference

standard (lot 939419)

5 - MiV-PA - Introduction of a new working cell bank

(WCB) No. 572912 using the procedure of current WCB

No.915331, from the same master cell bank (MCB

No.L38801)


Bhd

3 (643)/DRU/DRA.Variation/2018 Humalog Mix25 100units/ml

Kwikpen

Insulin Lispro 100IU/ml [In the

proportion of 25% Insulin

Lispro & 75% Insulin Lispro

Protamine Suspension (rDNA

origin)


the drug product (inlcuding replacement or addition of a

test procedure)


Bhd

141st DRC Meeting (85 Applications)


LAMPIRAN C

4 (644)/DRU/DRA.Variation/2018 Humalog Mix50 100

units/ml Kwipen

Insulin Lispro * 100IU/ml

(equivalent to 3.5mg) * in the

proportion of 50% insulin

lispro solution and 50% insulin

lispro protamine suspension

(rDNA) origin


the drug product (inlcuding replacement or addition of a

test procedure)


Bhd

5 (713)/DRU/DRA.Variation/2018 Axcel Cefuroxime - 250

Capsule

Cefuroxime (as axetil) 250mg BRU09040230P 1 - MiV-PA13 (Minor) - Change of batch size of non-


2 - MiV-PA15 (Minor) - Quantitative change of excipient

Medicorp Sdn Bhd

6 (760)/DRU/DRA.Variation/2019 Betamethasone cream Betamethasone (as valerate)

0.1%w/w

BRU09060268P 1 - MiV-PA1 (Minor) with consequential MiV-PA2 -

Change of drug product name with consequential change

of inner label and package insert (Version: EL201A-R9,

Revised Date: July 2017)





storage condition)

G&H Trading Company

7 (761)/DRU/DRA.Variation/2019 Miconazole Cream 2.0%

w/w

Miconazole Nitrate 2.0%w/w BRU08110159P 1 - MiV-PA1 (Minor) with consequential MiV-PA2 -

Change of drug product name with consequential change

of inner label, outer carton label and package insert

(Version: EL213A-R7, Revised Date: 11/04/2019

G&H Trading Company

8 (782)/DRU/DRA.Variation/2018 Metalyse Injection 10,000

units

Tenecteplase 10,000units

(50mg)

BRU09090327P 1 - MiV-PA (Minor) - Change in manufacturing procedure

of the drug substance

Hongkiat Trading &

Company

9 (800)/DRU/DRA.Variation/2018 Topamax® 25 Tablet 25mg Topiramate 25mg BRU14071385P 1 - MiV-PA2 (Minor) - Change in Package Insert (DATE OF

REVISION OF THE TEXT : 21 Nov 2018 (Based on CCDS v07

March 2018)


Bhd

10 (801)/DRU/DRA.Variation/2018 Topamax® 50 Tablet Topiramate 50mg BRU121109561P 1 - MiV-PA2 (Minor) - Change in Package Insert (DATE OF


March 2018)


Bhd

11 (802)/DRU/DRA.Variation/2018 Topamax® 100 Tablet

100mg

Topiramate 100mg BRU14121671P 1 - MiV-PA2 (Minor) - Change in Package Insert (DATE OF


March 2018)


Bhd

12 (803)/DRU/DRA.Variation/2018 Xalkori 200mg Hard

Capsules

Crizontinib 200mg BRU18082394P 1 - MaV-1 (Major) and (MaV-2) Addition of indication and

change in Package Insert (Version : XALKORI-0219, Date

of revision: 27 Feb 2019)


Bhd


Capsules

Crizontinib 250mg BRU18082395P 1 - MaV-1 (Major) and (MaV-2) Addition of indication and

change in Package Insert (Version : XALKORI-0219, Date

of revision: 27 Feb 2019)


Bhd


LAMPIRAN C


Capsules

Crizotinib 200mg BRU18082394P 1 - MiV-PA6 (Minor) - Change of in-process controls








4 - MiV-PA30 (Minor) - Change of pack size of container

for non-sterile product


Bhd


Capsules

Crizotinib 250mg BRU18082395P 1 - MiV-PA6 (Minor) - Change of in-process controls






3 - MiV-PA13 (Minor) - Change of batch size of on-sterile

drug product



5 - MiV-PA30 (Minor) - Change of pack size of container

for non-sterile product


Bhd


Tablet



120mg

BRU10080535PS2 1 - MiV-PA8 - Change of the specification of drug

substance (Pseudoephedrine)

Medipharm Sdn Bhd

17 (816)/DRU/DRA.Variation/2018 Requip PD 24hr Prolong

Release Tablet 2mg

Ropinirole 2mg (as

Hydrochloride)

BRU14071378P 1 - MiV-PA9 - Change of the test procedure of non-



(package insert; new date of revision 01 February 2018)


Bhd

18 (819)/DRU/DRA.Variation/2018 Pradaxa® Hard Capsules

75mg


mesilate 86.48mg)

BRU14021247P 1 - MiV-PA2 (Minor) - Change in package insert (date of

Revision : 6 September 2018)

Hongkiat Trading &

Company


110mg


mesilate 126.83mg)



Hongkiat Trading &

Company


150mg


mesilate 172.95mg)



Hongkiat Trading &

Company


LAMPIRAN C

21 (835)/DRU/DRA.Variation/2018 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

10µg, Haemophilus infleunzae

type b polysaccharide

(polyribosylribitol phosphate).

12µg, conjugated to Tetanus

protein (PRP-T) 22-36µg


the drug product


Bhd

22 (836)/DRU/DRA.Variation/2018 Flixotide™ Evohaler 50mcg Fluticasone Propionate 50mcg BRU14081427P 1 - MiV-PA2 (Minor) - Change in package insert (Version:

Flixotide Evohaler v03, Date of revision : 18 July 2018)


Bhd

23 (837)/DRU/DRA.Variation/2018 Flixotide™ Evohaler 125mcg Fluticasone Propionate

125mcg

BRU10120615P 1 - MiV-PA2 (Minor) - Change in package insert (Version:

Flixotide Evohaler v03, Date of revision : 18 July 2018)


Bhd

24 (838)/DRU/DRA.Variation/2018 Seretide Accuhaler 50/100 Salmeterol (as Xinafoate)

50mcg; Fluticasone Propionate

100mcg


Seretide Accuhaler v04, date of revision : 18 July 2018)


Bhd



250mcg




Bhd



500mcg




Bhd

27 (857)/DRU/DRA.Variation/2018 Primacor® 10mg/10ml

Injection

Milrinone 10mg/10ml (as

lactate)

BRU11120837P 1 - MiV-PA2 (Minor) - Change in package insert (Date of

Revision : 9th Mar 2018 (base on CCDSV 7 / SmPC 25 Jan

2018)

Medipharm Sdn Bhd

28 (858)/DRU/DRA.Variation/2018 Implanon NXT Implant 68mg Etonogestrel 68mg BRU15011734P 1 - MiV-PA2 (Minor) - Change in package insert (Version:

S-CDDS-MK8415-IPTx-092018a, Date of revision of the

text : September 2018)


Bhd

29 (861)/DRU/DRA.Variation/2018 Patanol® Eye Drops,

Solution 0.1%

Olopatadine (as HCI) 0.1% BRU14031263P,

BRU14031263PS2

1 - MiV-PA2 (Minor) - Change in package insert (Tracking

number : TDOC-0050045V.1.0, date of revision : March

2018)


Bhd


LAMPIRAN C

30 (862)/DRU/DRA.Variation/2018 Dostinex tablet 0.5mg Cabergoline 0.5mg BRU14021235P 1 - MiV-PA2 (Minor) - Change of inner label, Outer carton

label and package insert (date of revision : 02 Aug 2018,

Version: DOSTINEX-0818)

2 - MiV-PA28 (Minor) - Change in primary package

material for non-sterile product



storage condition)


Bhd

31 (866)/DRU/DRA.Variation/2018 Lipitor™ 10mg Tablet Atorvastatin (as calcium

10.85mg - crystalline) 10mg

BRU09110354P 1 - MaV-1 including MaV-2 (Major) - Change of package

insert (Date of revision: 08 Feb 2018, Version: Lipitor-

0218)


Bhd

32 (867)/DRU/DRA.Variation/2018 Lipitor 20mg Tablet Atorvastatin (Calcium) 20mg BRU10020416P 1 - MaV-1 including MaV-2 (Major) - Change of package


0218)


Bhd

33 (868)/DRU/DRA.Variation/2018 Lipitor™ 40mg Tablet Atorvastatin (as Calcium

43.38mg-crystalline) 40mg

BRU09100345P 1 - MaV-1 including MaV-2 (Major) - Change of package


0218)


Bhd

34 (871)/DRU/DRA.Variation/2018 Daunoblastina Injection

20mg

Daunoribicin Hydrochloride

20mg

BRU11090774P 1 - Major (MaV-1 including MaV-2) - Change of package

insert (Date of revision : 04 OCT 2018, Version:

DAUNOBLASTINA-1018)


Bhd

35 (873)/DRU/DRA.Variation/2018 Zyrtec® Oral Solution

1mg/ml

Cetrizine diHCI 1mg/ml (0.1%) BRU10050475P 1 - MiV-PA2 (Minor) - Change of package insert (Date of

revision : 18 July 2018, Version: Zyrtec v03, Reference:

NCDS05)


Bhd

36 (876)/DRU/DRA.Variation/2018 Uphamol Suspension 250

(Orange)

Paracetamol 250mg/5ml BRU10050466NP 1 - Major (MaV) - Change of product licence holder BINTANG RIA SDN BHD

37 (877)/DRU/DRA.Variation/2018 Uphamol Suspension 250

(Fruity)

Paracetamol 250mg/5ml BRU09100338NP 1 - Major (MaV) - Change of product licence holder BINTANG RIA SDN BHD

38 (879)/DRU/DRA.Variation/2018 Neurontin Capsule 300mg Gabapentin 300mg BRU09060272P 1 - MiV-PA35 (Minor) - Change of storage conditions of


storage condition)


Bhd

39 (881)/DRU/DRA.Variation/2018 Dilantin 100mg Capsule Phenytoin Sodium 100mg BRU09120367P 1 - MiV-PA2 (Minor) - Change of package insert (Date of

revision: 29 Oct 2018, version : DILANTIN CAPSULE-1018)


Bhd

40 (882)/DRU/DRA.Variation/2018 Dilantin Capsule 30mg Phenytoin Sodium 30mg BRU15091929P 1 - MiV-PA2 (Minor) - Change of package insert (Date of

revision: 29 Oct 2018, version : DILANTIN CAPSULE-1018)


Bhd

41 (883)/DRU/DRA.Variation/2018 Vfend 50mg film-coated

Tablet

Voriconazole 50mg BRU11060716P 1 - MiV-PA2 (Minor) - Change of outer carton label and

package insert (date of revision: 15 Nov 2017, Version:

VFEND-1117)



storage condition)


Bhd

42 (884)/DRU/DRA.Variation/2018 Vfend ™ Film-coated Tablets

200mg

Voriconazole 200mg BRU11040684P 1 - MiV-PA2 (Minor) - Change of outer carton label and

package insert (date of revision: 15 Nov 2017, Version:

VFEND-1117)



storage condition)


Bhd


LAMPIRAN C

43 (885)/DRU/DRA.Variation/2018 Vfend Powder For Oral

Suspension 40mg/ml

Voriconazole 40mg/ml BRU14071380P 1 - MiV-PA2 (Minor) - Change of inner label, outer carton

label and package insert (date of revision: 15 Nov 2017,

Version: VFEND-1117)


Bhd

44 (886)/DRU/DRA.Variation/2018 Vfend™ IV 200mg Voriconazole 200mg BRU12050897P 1 - MiV-PA2 (Minor) - Change of inner label, outer carton

label and package insert (date of revision: 15 Nov 2017,

Version: VFEND-1117)


Bhd

45 (887)/DRU/DRA.Variation/2018 Prostin VR Paediatric®

Sterile Solution 500mcg

Alprostadil 500mcg/ml BRU10080532P 1 - MiV-PA2 (Minor) - Change of inner label and outer

carton label


Bhd

46 (888)/DRU/DRA.Variation/2018 Champix 0.5mg & 1mg

Tablet

Varenicline Tartrate 0.5mg &

1mg

BRU13081115P 1 - MaV-3 (Major) with consequential Minor (MiV-PA) -

Addition of alternative manufacturer of drug substance


Suitability (CEP) is not available) with consequential

update of dossier section

2 - MiV-PA (Minor) - To update the ACLAR/PVC blister

film supplier detail


Bhd

47 (889)/DRU/DRA.Variation/2018 Champix 1mg Film-coated

Tablet

Varenicline Tartrate 1mg BRU13071099P 1 - MaV-3 (Major) with consequential Minor (MiV-PA) -

Addition of alternative manufacturer of drug substance


Suitability (CEP) is not available) with consequential

update of dossier section

2 - MiV-PA (Minor) - To update the ACLAR/PVC blister

film supplier detail


Bhd

48 (890)/DRU/DRA.Variation/2018 Jakavi 5mg Tablet Ruxolitinib (as phosphate

6.6mg) 5 mg

BRU15041837P 1 - MiV-PA2 (Minor) - Change of package insert (date of

revision : Feb 2018, Tracking number: 2017-PSB/GLC-

0878-s)


Bhd

49 (891)/DRU/DRA.Variation/2018 Jakavi 10mg Tablet Ruxolitinib phosphate 13.2mg

eq. to 10mg Ruxolitinib



0878-s)


Bhd

50 (892)/DRU/DRA.Variation/2018 Jakavi 15mg Tablet Ruxolitinib phosphate 19.8mg

eq. to 15mg Ruxolitinib



0878-s)


Bhd

51 (893)/DRU/DRA.Variation/2018 Jakavi 20mg Tablet Ruxolitinib (as phosphate

26.40mg) 20 mg



0878-s)


Bhd

52 (894)/DRU/DRA.Variation/2018 Voluven Solution for

Infusion 6%

Per 1000ml: Poly (o-2-

hydroxyethyl) starch 60.0g;

Sodium chloride 9.00g

BRU15041854NP 1 - MiV-PA2 (Minor) - Change of inner label and package

insert (date of revision: August 2017, Version:

0731131/00 MY)



storage condition)


Bhd

53 (895)/DRU/DRA.Variation/2018 Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml

(equivalent to 14.2mg)

BRU14031250PS1 1 - MiV-PA2 (Minor) - Change in inner label, outer carton

label and package insert (2018)



storage condition)


Bhd


LAMPIRAN C

54 (896)/DRU/DRA.Variation/2018 Tobradex® Eye Drops

Suspension

Tobramycin 0.3%;

Dexamethasone 0.1%

BRU14081467P 1 - MiV-PA2 (Minor) - Change in inner label, outer carton

label and package insert (Date of revision: 07-2016)



storage condition)


Bhd

55 (897)/DRU/DRA.Variation/2018 Lucrin® depot 3.75mg

Injection

Leuproprelin acetate 3.75mg BRU14071388P 1 - MiV-PA35 (Minor) with consequential (MiV-PA2) -

Change of storage conditions of the drug product

(increasing from the current approved stoarge condition)

with consequential change in inner label, outer carton

label and package insert (Date revised : July 2018

CCDS03671017)


Bhd

56 (905)/DRU/DRA.Variation/2018 DuoTrav Eye Drops, Solution Travoprost 40mcg/ml; Timolol

5mg/ml (as timolol maleate)

BRU14041297PS1 1 - MaV-6 (Major) - Change of the specification drug

substance [where European Pharmacopoeial Certificate

of Suitability (CEP) is not available]

2 - MiV-PA2 (Minor) - Change in inner label, outer carton

label, pouch label and package insert (Tracking number:

TDOC 0016604 Version 2.0, Date of revision: February

2018)


Bhd

57 (906)/DRU/DRA.Variation/2018 Betoptic S Eye Drops Betaxolol 2.5mg/ml (as

Hydrochloride 2.8mg)

BRU14091504P 1- MiV-PA27 (Minor) - Change in test procedure of the

drug product


Bhd

58 (907)/DRU/DRA.Variation/2018 Axcel Cinnarizine Tablet Cinnarizine 25mg BRU17012142P 1 - MaV-6 (Major) including Minor (MiV-PA24) and (MiV-

PA27) - Change of specification of the drug product


Suitability (CEP) is not available) including change of

release and shelf-life specification of the drug product

and change in test procedure of the drug product

Medicorp Sdn Bhd

59 (908)/DRU/DRA.Variation/2018 Axcel Diprodin Elixir Diphenhydramine HCI

12.5mg/5ml; Ephedrine HCI

6mg/5ml




specification of the drug product

Medicorp Sdn Bhd

60 (909)/DRU/DRA.Variation/2018 Axcel Aciclovir Cream

5%w/w

Aciclovir 5%w/w BRU08110153P 1 - Major (MaV-6) including Minor (miV-PA24) and (MiV-

PA27) - Change of specification of the drug product


Suitability (CEP) is not available) including change of

release and shelf-life specification of the drug product

and change in test procedure of the drug product

Medicorp Sdn Bhd

61 (910)/DRU/DRA.Variation/2018 Zanidip® Tablet 10mg Lercanidipine Hydrochloride

10mg (eq. to 9.4mg

Lercanidipine)

BRU12020864P 1 - MiV-PA20 (Minor) - Minor change of the



Bhd

62 (911)/DRU/DRA.Variation/2018 Zanidip® 20mg Tablet Lercanidipine HCI 20mg BRU13010985P 1 - MiV-PA20 (Minor) - Minor change of the



Bhd


LAMPIRAN C

63 (912)/DRU/DRA.Variation/2018 Cervarix™ Vaccine (Prefilled

Syringe)


Human Papilomavirus type 16

L1 protein 20mcg; Human

Papilomavirus type 18 L1

protein 20mcg; 3-O-desacyl-4¹-

monophosphoryl lipid A (MPL)

50mcg; adsorbed on

aluminium hydroxide,

hydrated (AI (OH)³) 0.5mcg

Al3+

BRU12120967P 1 - MaV-1 (Major) - change of indication extending the

usage of the product include change in package insert

(Version number : 01, reference: GDS024 / IPI019, Date

of local revision : 26 February 2018)

2 - MiV-PA2 (Minor) - Change in inner label and outer

carton label


Bhd


Syringe)







50mcg; adsorbed on



Al3+

BRU12120967P 1 - MiV-PA9 (Minor) - Change of the test procedure of

non-compendial drug substance intermediates


Bhd


Syringe)







50mcg; adsorbed on



Al3+

BRU12120967P 1 - MiV-PA20 (Minor) - Minor change of the

manufacturing process for drug product alignment of

registration dossier with current operational practices

and editorial changes

2 - MiV-PA22 (Minor) - Change of test procedure of

excipient (alignment of dossier with current operational

practices)


the drug product


Bhd


LAMPIRAN C

66 (915)/DRU/DRA.Variation/2018 Synflorix™ Vaccine 1 dose (0.5ml) contains :


serotype 1¹´² - 1mcg,






serotype 6B¹´² - 1mcg,


serotype 7F¹´² - 1mcg,


serotype 9V¹´² - 1mcg,




serotype 18C¹´³ - 3mcg,


serotype 19F¹´⁴ - 3mcg,


serotype 23F¹´²- 1mcg Note :

¹adsorbed on aluminium

phosphate - 0.5mg AI³⁺·¸²


(derived from non-typeable


protein - 9-16mcg;³

conjugated to tetanus toxoid

carrier protein -5-10mcg;⁴

conjugated to diptheria toxoid

carrier protein - 3-6mcg

BRU111208190.5gV &

BRU11120819P0.5gS

1 - MaV-1 (Major) - Addition of patient population

extending the usage of the product (date of revision : 23

Nov 2018, Version number : 02, Reference:

GDS017/IPI017)


Bhd

67 (918)/DRU/DRA.Variation/2018 Toviaz 4mg prolonged-

release tablet

Fesoterodine fumarate

equivalent to 3.1mg

fesoterodine

BRU15021784P 1 - MiV-PA2 - Change of content of product labelling

(outer carton and package insert, version TOVIAZ-1217

date of revision : 15 Dec 2017)


Bhd

68 (919)/DRU/DRA.Variation/2018 Toviaz 8mg prolonged-

release tablet

Fesoterodine fumarate

equivalent to 6.2mg

fesoterodine

BRU15021785P 1 - MiV-PA2 - Change of content of product labelling

(outer carton and package insert, version TOVIAZ-1217

date of revision : 15 Dec 2017)


Bhd

69 (920)/DRU/DRA.Variation/2018 Protopic Ointment 0.03% Tacrolimus 0.3mg/g (0.03%) BRU14071320P 1 - MiV-PA2 - Change of product labelling (outer carton,

inner tube and package insert, new date of revision: July

2018 (CCDS 31 August 2010)


Bhd

70 (921)/DRU/DRA.Variation/2018 Protopic Ointment 0.1% Tacrolimus (as Tacrolimus

monohydrate) 0.1%

BRU14081418P 1 - MiV-PA2 - Change of product labelling (outer carton,

inner tube and package insert, new date of revision: July

2018 (CCDS 31 August 2010)


Bhd


LAMPIRAN C

71 (926)/DRU/DRA.Variation/2018 Cetrotide Injection 0.25mg Cetrotrelix 0.25mg (as Acetate) BRU14091479PS1;

BRU14091479PS2

1 - MaV-7 - Increase the batch size for the manufacturing

process of drug product manufactured at Baxter

Oncology GmbH, Germany

G&H Trading Company

72 (929)/DRU/DRA.Variation/2018 Trileptal Film-coated Tablets

300mg

Oxcarbazepine 300mg BRU14111558P 1 - MiV-PA15 (Minor) - Qualitative or quantitative change

of excipient


manufacturing process for non-sterile drug product

3 - MiV-PA21 - Change of specification of excipients

(Delete non-specific test of 'Odour' as this test constitute

a major occupational health and safety risk)


Bhd

73 (930)/DRU/DRA.Variation/2018 Typhim Vi Vaccine (20

doses)

Per 0.5ml - purified Vi Capsular

Polysaccharide of Salmonella

typhi (Ty2 strain)

BRU09040238P 1 - MaV-9 - Major change in the manufacturing process

for the drug product


Bhd

74 (935)/DRU/DRA.Variation/2018 Caelyx 2mg/ml Concentrate

for Infusion

Doxorubicin HCI 2mg/ml BRU11030669PS1;

BRU11030669PS2

1 - MiV-PA10 (Minor) - Change of shelf-life drug

substance

2 - MiV-N8 (Minor) - Renewal of European

Pharmacopoeial Certificate of Suitability (CEP)


Bhd

75 (937)/DRU/DRA.Variation/2018 Eligard® Powder and

Solvent for Solution for

Injection 7.5mg

Leuproprelin Acetate 7.5mg



(syringe A) : Poly (DL-lactic-co-


methylpyrrolidine

BRU18062353P 1 - MiV-PA2 (Minor) - Change in package insert (Issue

date: Sep/2018


(primary) packaging not in contact with the finished

product formulation

3 - Miv-N (Minor) - Update of CTD P.7 Container Closure

System (including change of test method number for

packaging component)

Medipharm Sdn Bhd



Injection 22.5mg

Leuproprelin Acetate 22.5mg



(syringe A) : Poly (DL-lactic-co-


methylpyrrolidine

BRU18062354P 1 - MiV-PA 2 (Minor) - Change in package insert (Issue

date: Sep/2018)



product formulation

3 - Miv-N (Minor) - Update of CTD P.7 Container Closure



Medipharm Sdn Bhd



Injection 45mg

Leuproprelin Acetate 45 mg



(Syringe A): Poly (DL-lactic-co-


methylpyrrolidine

BRU180062355P 1 - MiV-PA2 (Minor) - Change in package insert (Issue

date: Sep/2018)



product formulation

3 - MiV-N (Minor) - Update of CTD P.7 Container Closure



Medipharm Sdn Bhd


LAMPIRAN C

78 (943)/DRU/DRA.Variation/2018 Carzepin 200mg Tablet Carbamazepine 200mg BRU14081439P 1 - MiV-PA2 (Minor) - Change of outer carton label and

package insert (Date of revision: July 2018)



storage condition)

G&H Trading Company

79 (944)/DRU/DRA.Variation/2018 Cetamacrogol emulsifying

ointment

Cetomacragol emulsifying wax

30% w/w; liquid paraffin 20%;

white soft paraffin 50%

BRU15041851NP 1 - MiV-PA2 (Minor) - Change of packaging label G&H Trading Company

80 (945)/DRU/DRA.Variation/2018 Clofenac SR Tablet Diclofenac Sodium 100mg BRU14081473P 1 - MiV-PA2 (Minor) - Change of outer carton label and

package insert (Version: VICLOXX-M3, date of revision:

June 2017)



storage condition)

G&H Trading Company

81 (946)/DRU/DRA.Variation/2018 Diabetmin Film-coated

Tablet 500mg

Metformin HCI 500mg BRU11090772P 1 - MiV-PA2 (Minor) - Change of outer carton label G&H Trading Company

82 (947)/DRU/DRA.Variation/2018 Doxycap capsule 100mg Anhydrous Doxycycline 100mg BRU13031043P 1 - MiV-PA2 (Minor) - Change of outer carton label and

package insert (Version: VIDOX06-0 (MY), Date of

revision: May 2018)



storage condition)

G&H Trading Company

83 (948)/DRU/DRA.Variation/2018 Glimicron 80mg Tablet Gliclazide 80mg BRU16022000P 1 - MiV-PA2 (Minor) - Change of outer carton label and

package insert (Version: VIGLI10-0 (MY), Date of revision:

May 2015)



storage condition)

G&H Trading Company

84 (949)/DRU/DRA.Variation/2018 Setrof Tablet 50mg Sertraline 50mg BRU14071405P 1 - MiV-PA2 (Minor) - Change of blister artwork, outer

carton label and package insert (Version: VISET11-0 (MY),

Information date : January 2017)

G&H Trading Company

85 (602)/DRU/DRA.Variation/2018 Alphanate 250IU Factor VII 250IU and von

Villebrand Factor

>400IU/1000IU Factor VII

BRU16082066NP 1- MiV-PA24 (Minor) - Change of release and shelf-life

specifications of the drug product 2 - MiV-

PA27 (Minor) -Change in the test procedure of the drug

product (including replacement or addition of a test

procedure)

Hongkiat Trading &

Company


LAMPIRAN C


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