LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd,...

12
1 BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 21 Jun 2021 till 20 Jun 2026 2 BRU11100785P Atorvastatin Winthrop® 10mg Film-Coated Tablets Atorvastatin 10mg (as Calcium 10.34mg) Saneca Pharmaceuticals a.s., Slovak Republic MediPharm Sdn Bhd 31 October 2016 till 30 October 2021 31 October 2021 till 30 October 2026 3 BRU11040697P Atorvastatin Winthrop® 20mg Film-Coated Tablet Atorvastatin 20mg (as Calcium 20.68mg) Saneca Pharmaceuticals a.s., Slovak Republic Medipharm Sdn Bhd 30 April 2016 till 29 April 2021 30 April 2021 till 29 April 2026 4 BRU11060721P Atorvastatin Winthrop® 40mg Tablet Atorvastatin 40mg (as Calcium 41.36mg) Saneca Pharmaceuticals a.s., Slovak Republic Medipharm Sdn Bhd 02 July 2016 till 01 July 2021 02 July 2021 till 01 July 2026 5 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mg Sunward Pharmaceutical Pte Ltd., Singapore G & H Trading Company 25 May 2016 till 24 May 2021 25 May 2021 till 24 May 2026 6 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mg Sunward Pharmaceutical Pte Ltd, Singapore G & H Trading Company 27 September 2016 till 26 September 2021 27 September 2021 till 26 September 2026 7 BRU15121974P Paracetamol Codeine Tablet Paracetamol 500mg and Codeine Phosphate 8mg Sunward Pharmaceutical Pte. Ltd., Singapore G & H Trading Company 21 Jun 2016 till 20 Jun 2021 21 Jun 2021 till 20 Jun 2026 8 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mg Sunward Pharmaceutical Pte Ltd., Singapore G & H Trading Company 30 April 2016 till 29 April 2021 30 April 2021 till 29 April 2026 LIST OF RENEWED PRODUCT LICENCES BY THE BRUNEI DARUSSALAM MEDICINES CONTROL AGENCY (BDMCA) IN THE 35TH BDMCA MEETING ON 19 AUGUST 2020 Product Licence no. No. Product Name Active Ingredient(s) Validity period following renewal Manufacturer Licence Holder Validity of the licence

Transcript of LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd,...

Page 1: LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 06 October

1 BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100%HOVID Bhd,

Malaysia

G & H Trading

Co

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

2 BRU11100785P

Atorvastatin

Winthrop® 10mg

Film-Coated

Tablets

Atorvastatin 10mg (as Calcium

10.34mg)

Saneca

Pharmaceuticals

a.s., Slovak

Republic

MediPharm Sdn

Bhd

31 October 2016

till 30 October

2021

31 October 2021

till 30 October

2026

3 BRU11040697P

Atorvastatin

Winthrop® 20mg

Film-Coated Tablet

Atorvastatin 20mg (as Calcium

20.68mg)

Saneca

Pharmaceuticals

a.s., Slovak

Republic

Medipharm Sdn

Bhd

30 April 2016 till

29 April 2021

30 April 2021 till

29 April 2026

4 BRU11060721P

Atorvastatin

Winthrop® 40mg

Tablet

Atorvastatin 40mg (as Calcium

41.36mg)

Saneca

Pharmaceuticals

a.s., Slovak

Republic

Medipharm Sdn

Bhd

02 July 2016 till 01

July 2021

02 July 2021 till

01 July 2026

5 BRU11050702PBenzhexol Tablet

2mgBenzhexol HCl 2mg

Sunward

Pharmaceutical

Pte Ltd.,

Singapore

G & H Trading

Company

25 May 2016 till

24 May 2021

25 May 2021 till

24 May 2026

6 BRU11090762PProperazine Tablet

5mgProchlorperazine maleate 5mg

Sunward

Pharmaceutical

Pte Ltd,

Singapore

G & H Trading

Company

27 September

2016 till 26

September 2021

27 September

2021 till 26

September 2026

7 BRU15121974PParacetamol

Codeine Tablet

Paracetamol 500mg and

Codeine Phosphate 8mg

Sunward

Pharmaceutical

Pte. Ltd.,

Singapore

G & H Trading

Company

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

8 BRU11040682PSunolut Tablet

5mgNorethisterone 5mg

Sunward

Pharmaceutical

Pte Ltd.,

Singapore

G & H Trading

Company

30 April 2016 till

29 April 2021

30 April 2021 till

29 April 2026

LIST OF RENEWED PRODUCT LICENCES BY THE BRUNEI DARUSSALAM MEDICINES CONTROL AGENCY (BDMCA) IN THE 35TH BDMCA

MEETING ON 19 AUGUST 2020

Product Licence no.No. Product Name Active Ingredient(s)Validity period

following renewalManufacturer Licence Holder

Validity of the

licence

Page 2: LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 06 October

9 BRU11070727PSW Bena-

Expectorant

Per 5ml: Diphenhydramine HCl

10mg, Ammonium Chloride

102mg, Sodium Citrate 46mg

Sunward

Pharmaceutical

Pte Ltd.,

Singapore

G&H Trading

Company

27 July 2016 till 26

July 2021

27 July 2021 till

26 July 2026

10 BRU15121973PSW-Dexasone

TabletDexamethasone 0.5mg

Sunward

Pharmaceutical

Pte. Ltd.,

Singapore

G & H Trading

Company

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

11 BRU11040690PEngerixTM-B

Paediatric Vaccine

10mcg/0.5ml

Purified HBs-Ag 10mcg

GlaxoSmithKline

Biologicals SA.,

Rixensart

Belgium;

GlaxoSmithKline

Biologicals S.A.,

Wavre

Belgium

Zuellig Pharma

(B) Sdn Bhd

30 April 2016 till

29 April 2021

30 April 2021 till

29 April 2026

12BRU16032015PS1

&

BRU16032015PS2

M-M-R II® Vaccine

Live, attenuated virus derived

from Edmonston B strain of

measles - 3.0 log TCID50, Live

attenuated Jeryl LynnTM strain of

mumps - 4.1 log TCID50, Live,

attenuated Wistar RA 27/3

strain of rubella - 3.0 log TCID50

1. Merck Sharp &

Dohme Corp.,

Pennsylvania,

USA,

2. Merck Sharp &

Dohme Corp.,

North Carolina,

U.S.A

Zuellig Pharma

(B) Sdn Bhd

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

13BRU15121972PS1

&

BRU15121972PS2

Varivax

(refrigerated)

Varicella Virus Vaccine Live (Oka

/ Merck) 1350PFU / 0.5ml

Merck Sharp &

Dohme Corp.,

Pennsylvania

USA (S1)

ii) Merck Sharp

and Dohme

Corp., North

Carolina, US (S2)

Zuellig Pharma

(B) Sdn Bhd

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

14 BRU11090764P

Eloxatin 5mg/ml

Concentrate for

Solution for

Infusion (10ml)

Oxaliplatin 50mg/10ml

Sanofi-Aventis

Deutschland

GmbH, Germany

Medipharm Sdn

Bhd

27 September

2016 till 26

September 2021

27 September

2021 till 26

September 2026

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15 BRU11090765P

Eloxatin 5mg/ml

Concentrate for

Solution for

Infusion (20ml)

Oxaliplatin 100mg/20ml

Sanofi-Aventis

Deutschland

GmbH, Germany

Medipharm Sdn

Bhd

27 September

2016 till 26

September 2021

27 September

2021 till 26

September 2026

16 BRU11050708NPEssentiale Forte N

Capsule

Phospholipids fatty mass 392mg

(equivalent to 300mg

phospholipids from soya beans

containing 76% of (3-sn-

phosphatidyl) choline)

A. Nattermann &

Cie. GmbH.,

Germany

Medipharm Sdn

Bhd

25 May 2016 till

24 May 2021

25 May 2021 till

24 May 2026

17 BRU08120169PCloxacillin Capsule

250Cloxacillin (as Sodium) 250mg

Upha

Pharmaceutical

Mfg (M) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

18 BRU08060075PGenta-Dex Eye

Drops

Gentamicin 0.3% w/v;

Dexamethsone Phosphate

0.1%w/v

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

19 BRU14111642P

Manace Injection

5mg/ml

(Haloperidol

5mg/ml)

Haloperidol 5mg/ml

Duopharma (M)

Sdn Bhd

Malaysia

Hongkiat

Trading & Co

19 May 2015 till

18 May 2020

19 May 2020 till

18 May 2025

20 BRU15031818NPTempol Tablet

500mgParacetamol Tablet 500mg

Duopharma (M)

Sdn. Bhd.,

Malaysia

Hongkiat

Trading &

Company

19 May 2015 till

18 May 2020

19 May 2020 till

18 May 2025

21 BRU08040043P Zoraxin Suspension Aciclovir 200mg/5ml

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

22 BRU08020016PAnikef Sterile

750mgCefuroxime 750mg

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

23 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

24 BRU15091940P

Pirimat Injection

10mg/ml (1ml

ampoule)

Chlorpheniramine Maleate

10mg/ml

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

09 Dec 2015 till 08

Dec 2020

09 Dec 2020 till

08 Dec 2025

25 BRU08050060PUnocef Injection

500mg (Vial)Ceftriaxone (as Sodium) 500mg

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

Page 4: LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 06 October

26 BRU08050061PUnocef Injection

1000mg (Vial)Ceftriaxone (as Sodium) 1000mg

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

27 BRU10120607PAllopurinol Tablet

300mgAllopurinol 300mg

Y.S.P Industries

(M) Sdn Bhd,

Malaysia

Asterix United

(B) Sdn Bhd

29 December

2015 till 28

December 2020

29 December

2020 till 28

December 2025

28 BRU10100578PAxol Liquid

3mg/ml

Ambroxol Hydrochloride

3mg/ml

Y.S.P. Industries

(M) Sdn Bhd,

Malaysia.

Asterix United

(B) Sdn Bhd

28 October 2015

till 27 October

2020

28 October 2020

till 27 October

2025

29 BRU15111963P Elan Forte CreamTolnaftate 10mg/g;

Chlorhexidine HCl 2mg/g

Y.S.P. Industries

(M) Sdn.

Bhd.,Malaysia

Asterix United

(B) Sdn Bhd.

09 Dec 2015 till 08

Dec 2020

09 Dec 2020 till

08 Dec 2025

30 BRU11010642PVirless Tablets

200mgAcyclovir 200mg

Y.S.P Industries

(M) Sdn Bhd,

Malaysia

Asterix United

(B) Sdn Bhd

26 January 2016

till 25 January

2021

26 January 2021

till 25 January

2026

31 BRU10020405PVascor Tablet

20mgSimvastatin 20mg

Upha

Pharmaceuticals

Mfg (M) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

32 BRU09120377PVascor 40mg Film-

coated TabletSimvastatin 40mg

Upha

Pharmaceuticals

Mfg (M) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

33 BRU11010640PMicrogynon® 30

Tablet

Levonorgestrel 0.15mg,

Ethinylestradiol 0.03mg

Bayer Weimar

GmbH und Co.,

KG, Germany

Zuellig Pharma

(B) Sdn Bhd

26 January 2016

till 25 January

2021

26 January 2021

till 25 January

2026

34 BRU11070730P

Mirena®

Intrauterine

System

20mcg/24hr

Levonorgestrel 52mgBayer Oy,

Finland

Zuellig Pharma

(B) Sdn Bhd

27 July 2016 till 26

July 2021

27 July 2021 till

26 July 2026

35 BRU15081913NPZentel Suspension

400mg/10mlAlbendazole 400mg/10ml

Smithkline

Beecham,

Philippines

Kingston

Beverage &

Creamery Sdn

Bhd

09 Dec 2015 till 08

Dec 2020

09 Dec 2020 till

08 Dec 2025

36 BRU10050468P

Remicade Powder

for Concentrate for

Solution for

Infusion

100mg/vial

Infliximab (cA2 IgG) 100mg/vial Cilag AG,

Switzerland

Zuellig Pharma

(B) Sdn Bhd

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

Page 5: LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 06 October

37 BRU11110815PGranocyte® 34

Injection

Lenograstim (rHug-CSF) 33.6

million IU (equiv. to 263 mcg)/

vial

Sanofi Winthrop

Industrie, France

MediPharm Sdn

Bhd

24 November

2016 till 23

November 2021

24 November

2021 till 23

November 2026

38 BRU12100950P QvarTM 100 InhalerBeclomethasone dipropionate

100mcg per inhalation

3M Health Care

Limited, England

Zuellig Pharma

(B) Sdn Bhd

31 October 2016

till 30 October

2021

31 October 2021

till 30 October

2026

39 BRU11050712PTracrium Injection

25mg/2.5ml

Atracurium besylate

25mg/2.5ml

GlaxoSmithKline

Manufactuirng

S.p.A., Italy

Zuellig Pharma

(B) Sdn Bhd

25 May 2016 till

24 May 2021

25 May 2021 till

24 May 2026

40 BRU11040679PTrandateTM

Injection 5mg/ml x

5ml

Labetalol HCl 25mg/5ml

Hsinchu Plant of

UBI Pharma Inc.,

Taiwan

Zuellig Pharma

(B) Sdn Bhd

30 April 2016 till

29 April 2021

30 April 2021 till

29 April 2026

41 BRU16042036P

Pharmaniaga

Allopurinol Tablet

300mg

Allopurinol 300mg

Pharmaniaga

Manufacturing

Berhad,

Malaysia.

G & H Trading

Company

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

42 BRU16011992P

Pharmaniaga

Gliclazide Tablet

80mg

Gliclazide 80mg

Pharmaniaga

Manufacturing

Berhad, Malaysia

G&H Trading

Company

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

43 BRU08070096PBetamox Capsule

250mg

Amoxicillin Trihydrate

equivalent to Amoxicillin 250mg

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

44 BRU08100135PBetamox Capsule

500mg

Amoxicillin Trihydrate

equivalent to Amoxicillin 500mg

Duopharma (M)

Sdn Bhd

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

45 BRU08020018PBetamox Granules

125mg/5mlAmoxicillin 125mg/5ml

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

46 BRU08020019PBetamox Granules

250mg/5mlAmoxicillin 250mg/5ml

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

47 BRU10100576PAlbutein® Solution

for Infusion 25% Albumin (Human) 25%

Grifols

Biologicals LLC.,

USA

Hongkiat

Trading &

Company

28 October 2015

till 27 October

2020

28 October 2020

till 27 October

2025

48 BRU10040454NP ColimixTM Syrup

Per 5ml - Simethicone (activated

dimethicone) 50mg; dicylcomine

HCl 5mg

Xepa-Soul

Pattinson

(Malaysia) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

Page 6: LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 06 October

49 BRU15111967P Cough-En Linctus

Dextromethorphan

Hydrobromide 15mg/5ml;

Tripolidine Hydrochloride

1.25mg/5ml;

Pseudoephedrine Hydrochloride

30mg/5ml

Xepa-Soul

Pattinson

(Malaysia) Sdn.

Bhd., Malaysia

Hongkiat

Trading &

Company

09 Dec 2015 till 08

Dec 2020

09 Dec 2020 till

08 Dec 2025

50 BRU09120379P

Covastin Film-

coated Tablet

10mg

Simvastatin 10mg

Xepa-Soul

Pattinson

(Malaysia) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

51 BRU15101955P Ezede Tablet 10mg Loratadine 10mg

Xepa-Soul

Pattinson (M)

Sdn Bhd.,

Malaysia

Hongkiat

Trading & Co

09 Dec 2015 till 08

Dec 2020

09 Dec 2020 till

08 Dec 2025

52 BRU11120839PEpilim® 200 Enteric

Coated TabletsSodium Valproate 200mg

Sanofi-Aventis

S.A., Spain

MediPharm Sdn

Bhd

22 December

2016 till 21

December 2021

22 December

2021 till 21

December 2026

53 BRU11120834PHovasc Tablet

10mg

Amlodipine 10mg (as Besylate

13.8mg)

Hovid Bhd,

Malaysia

G & H Trading

Company

22 December

2016 till 21

December 2021

22 December

2021 till 21

December 2026

54 BRU11120832PClopivid Tablet

75mg

Clopidogrel 75mg (as hydrogen

sulphate 97.90mg)

Hovid Bhd,

Malaysia

G & H Trading

Company

22 December

2016 till 21

December 2021

22 December

2021 till 21

December 2026

55

BRU15021760PS1

&

BRU15021760PS2

Insulatard

100IU/ml

Suspension for

Injection (vial)

1ml of suspension contain 100IU

(3.5g) of insulin

Novo Nordisk

A/S, Denmark

(S1); Novo

Nordisk

Production SAS,

France (S2)

Zuellig Pharma

(B) Sdn Bhd

19 May 2015 till

18 May 2020

19 May 2020 till

18 May 2025

56 BRU10020413POptizoline eye

dropsTetrahydrozoline HCl 0.05%w/w

Xepa-Soul

Pattinson

(Malaysia) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

57 BRU10050470PPristinex Cream 2%

w/wKetoconazole 2% w/w

Xepa-Soul

Pattinson

(Malaysia) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

Page 7: LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 06 October

58 BRU10050474PProvinace Tablet

4mgPerindopril Erbumine 4mg

Xepa-Soul

Pattinson

(Malaysia) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

59 BRU10040455PXepanicol® Eye

Drops 0.5%Chloramphenicol 0.5%

Xepa-Soul

Pattinson

(Malaysia) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

60 BRU10070515P Zaricort CreamMiconazole Nitrate 2% w/w;

Hydrocortisone 1% w/w

Xepa-Soul

Pattinson (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

61 BRU11020643PDalacin C 300mg

Capsule

Clindamycin (as Hydrochloride)

300mg

Fareva Amboise,

France

Zuellig Pharma

(B) Sdn Bhd

24 February 2016

till 23 February

2021

24 February 2021

till 23 February

2026

62 BRU15071905P

Proglutrol 500

Extended Release

Tablets

Metformin Hydrochloride

500mg

Inventia

Healthcare Ltd.,

India

Medicorp Sdn

Bhd

09 Dec 2015 till 08

Dec 2020

09 Dec 2020 till

08 Dec 2025

63

BRU11040676PS1

;

BRU11040676PS2

Tazocin EF 4.5gPiperacillin (asmonohydrate) 4g;

Tazobactam (as sodium) 0.5g

Wyeth Lederle

S.r.I, Catania,

Italy (S1); Pfizer

Biotech

Corporation,

Hsinchu Plant,

Taiwan-Republic

of China (S2)

Zuellig Pharma

(B) Sdn Bhd

30 April 2016 till

29 April 2021

30 April 2021 till

29 April 2026

64 BRU11110809PDalacin CTM Sterile

Solution 150mg/ml

x 2ml ampoule

Clindamycin Phosphate 300mg

Pfizer

Manufacturing

Belgium N.V.,

Puurs, Belgium

Zuellig Pharma

(B) Sdn Bhd

24 November

2016 till 23

November 2021

24 November

2021 till 23

November 2026

65 BRU11040678P

Euvax B Adult

Vaccine

Recombinant

Purified HBs-Ag 20mcg LG Chem, Ltd,

Korea

Zuellig Pharma

(B) Sdn Bhd

30 April 2016 till

29 April 2021

30 April 2021 till

29 April 2026

66 BRU11050703PLevitra Film-coated

Tablets 10mg

Vardenafil (as

monohydrochloride trihydrate)

10mg

Bayer AG,

Leverkusen,

Germany

Zuellig Pharma

(B) Sdn Bhd

25 May 2016 till

24 May 2021

25 May 2021 till

24 May 2026

67 BRU11020650P

Levitra® film-

coated Tablet

20mg

Vardenafil (as monochloride

trihydrate) 20mg

Bayer AG.,

Leverkusen,

Germany

Zuellig Pharma

(B) Sdn Bhd

24 February 2016

till 23 February

2021

24 February 2021

till 23 February

2026

Page 8: LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 06 October

68 BRU09110359PAllavin

Expectorant

Diphenhydramine HCl

14mg/5ml; Ammonium Chloride

135mg/5ml

Duopharma

Manufacturing

(M) Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

69 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2%

Duopharma

Manufacturing

(M) Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

70 BRU09080311P Carinox CapsulePseudoephedrine sulphate

120mg; Loratadine 5mg

Duopharma

Manufacturing

(M) Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2015

till 05 October

2020

71 BRU08060079PEnoxin Tablet

500mgCiprofloxacin 500mg

Duopharma

Manufacturing

(M) Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

72 BRU08050068P Krisovin Tablet 500Griseofulvin BP 500mg

(micronised)

Duopharma

Manufacturing

(M) Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

73 BRU08060085PNeomycin Cream

0.5%Neomycin sulphate 0.5%w/w

Duopharma

Manufacturing

(M) Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

74 BRU09030227P Pocin H Ear Drop

Neomycin Sulphate B.P. 3,400

i.u.; Polymyxin B Sulphate

B.P.10,000 i.u; Hydrocortisone

B.P.10mg

Duopharma

Manufacturing

(M) Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

75 BRU11120837P

Primacor®

10mg/10ml

Injection

Milrinone 10mg/10ml (as

lactate)

Delpharm Dijon,

France

MediPharm Sdn

Bhd

22 December

2016 till 21

December 2021

22 December

2021 till 21

December 2026

Page 9: LIST OF RENEWED PRODUCT LICENCES BY THE ... Documents/Traditional Medicines...(Malaysia) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 06 October

76 BRU11080754PCoAprovel Tablet

300/25mg

Irbesartan 300mg,

Hydrochlorothiazide 25mg

Sanofi Winthrop

Industrie, France

Medipharm Sdn

Bhd

25 August 2016 till

24 August 2021

25 August 2021

till 24 August

2026

77 BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w

Rohto-

Mentholatum

(Vietnam) Co.

Ltd., Vietnam

Hamitan

Marketing

09 Dec 2015 till 08

Dec 2020

09 Dec 2020 till

08 Dec 2025

78 BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w

Rohto-

Mentholatum

(Vietnam) Co.

Ltd., Vietnam

Hamitan

Marketing

28 July 2015 till 27

July 2020

28 July 2020 till

27 July 2025

79 BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w

Rohto-

Mentholatum

(Vietnam) Co.

Ltd., Vietnam

Hamitan

Marketing

09 Dec 2015 till 08

Dec 2020

09 Dec 2020 till

08 Dec 2025

80 BRU11050707P

Caverject 20mcg

Powder and

solvent for

injection

Alprostadil 20µg

Pfizer

Manufacturing

Belgium N.V.,

Belgium

Zuellig Pharma

(B) Sdn Bhd

25 May 2016 till

24 May 2021

25 May 2021 till

24 May 2026

81 BRU11050701PDepo-Provera Vial

150mg/3ml

Medroxyprogesterone acetate

150mg

Pfizer

Manufacturing

Belgium N.V.,

Belgium

Zuellig Pharma

(B) Sdn Bhd

25 May 2016 till

24 May 2021

25 May 2021 till

24 May 2026

82 BRU15051863NP

SP Pharma

Paracetamol

Tablets 500mg

Paracetamol 500mg

Simpor Pharma

Sendirian

Berhad, Brunei

Darussalam

Simpor Pharma

Sendirian

Berhad

19 May 2015 till

18 May 2020

19 May 2020 till

18 May 2025

83 BRU08060081PBetagen Eye/ Ear

Drops

Gentamicin Sulphate equivalent

to Gentamicin 0.3%;

Betamethasone Sodium

Phosphate 0.1%

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

84 BRU08100137PNeo Deca Eye/Ear

Drop

Neomycin Sulphate 0.5%;

Dexamethasone Sodium

Phosphate 0.1% w/w

Duopharma (M)

Sdn Bhd,

Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

85 BRU15061881P

Norditrophin

Nordilet Inejction

5mg/1.5ml Pre-

filled Pen, Solution

for Injection

Somatropin (rDNA) 3.3mg/mlNovo Nordisk

A/S, Denmark

Zuellig Pharma

(B) Sdn Bhd

28 July 2015 till 27

July 2020

28 July 2020 till

27 July 2025

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86 BRU11070735PElosone Ointment

0.1%w/wMometasone furoate 0.1% w/w

HOE

Pharmaceuticals

Sdn Bhd.,

Malaysia

G & H Trading

Company

27 July 2016 till 26

July 2021

27 July 2021 till

26 July 2026

87 BRU11060715P

Oxy-Nase

Paediatric Nasal

Drop 0.025%w/v

Oxymetazoline HCl 0.025%

HOE

Pharmaceuticals

Sdn Bhd,

Malaysia

G & H Trading

Company

02 July 2016 till 01

July 2021

27 July 2021 till

26 July 2026

88 BRU16011997P Soluwax Ear Drops Docusate sodium 0.5% w/v

Hoe

Pharmaceuticals

Sdn Bhd.,

Malaysia

G&H Trading

Company

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

89 BRU10120617PIRESSATM Tablet

250mgGefitinib 250mg

Kagamiishi Plant,

Nipro Pharma

Corporation,

Fukushima,

Japan [packaging

and labelling site:

AstraZeneca

Pharmaceutical

Co. Ltd, Wuxi,

Jiangsu China]

Zuellig Pharma

(B) Sdn Bhd

29 December

2015 till 28

December 2020

29 December

2020 till 28

December 2025

90 BRU16011982NP

0.9% Sodium

Chloride Injection,

USP

Sodium Chloride USP 0.9%

Baxter

Healthcare

Corporation, USA

Zuellig Pharma

(B) Sdn Bhd

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

91 BRU09110362P Carin Tablet 10mg Loratadine 10mg

Upha

Pharmaceuticals

Mfg (M) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

92 BRU09120369P Oral Aid Lotion

Lignocaine HCl 2.5%;

Triamcinolone Acetonide 0.1%;

Chlorhexidine HCl 0.5%

Upha

Pharmaceuticals

Mfg (M) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

93 BRU15041862PSalmax CR tablet

4mgSalbutamol sulphate 4mg

Upha

Pharmaceuticals

Sdn Bhd,

Malaysia

Hongkiat

Trading & Co

19 May 2015 till

18 May 2020

19 May 2020 till

18 May 2025

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94 BRU09090324PTrenlin SR Tablet

400mgPentoxifylline 400mg

Upha

Pharmaceuticals

Mfg (M) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

95 BRU09110361NPUphamol 500

TabletParacetamol 500mg

Upha

Pharmaceuticals

Mfg (M) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

96 BRU09070287PZolterol S/R Tablet

100mgDiclofenac Sodium 100mg

Upha

Pharmaceuticals

Mfg (M) Sdn

Bhd, Malaysia

Hongkiat

Trading &

Company

06 October 2015

till 05 October

2020

06 October 2020

till 05 October

2025

97BRU11030669PS1

;

BRU11030669PS2

Caelyx 2mg/ml

Concentrate for

Infusion

Doxorubicin HCl 2mg/ml

Alza Corporation,

USA (S1);

GlaxoSmithKline

Manufacturing

S.P.A., Italy (S2)

Zuellig Pharma

(B) Sdn Bhd

26 March 2016 till

25 March 2021

26 March 2021

till 25 March

2026

98 BRU16022006PRocaltrol capsule

0.25mcgCalcitriol 0.25mcg

Catalent

Germany

Eberbach GmbH,

Germany for

F.Hoffmann-La

Roche Ltd.,

Switzerland

Hongkiat

Trading &

Company

21 Jun 2016 till 20

Jun 2021

21 Jun 2021 till

20 Jun 2026

99 BRU15021783PAcustop

CataplasmaFlurbiprofen 40mg

Green Cross

Corporation,

Korea

Zuellig Pharma

(B) Sdn Bhd

19 May 2015 till

18 May 2020

19 May 2020 till

18 May 2025

100 BRU15101947PCetyrol 10mg Film-

coated TabletCetirizine dihydrochloride 10mg

Salutas Pharma

GmbH, Germany

Zuellig Pharma

(B) Sdn Bhd

09 Dec 2015 till 08

Dec 2020

09 Dec 2020 till

08 Dec 2025

101 BRU11060718PMyleranTM Tablets

2mgBusulphan 2mg

Excella GmbH &

Co. KG, Germany

Zuellig Pharma

(B) Sdn Bhd

02 July 2016 till 01

July 2021

02 July 2021 till

01 July 2026

102 BRU11080744PLanoxin PG Tablet

0.0625mgDigoxin 0.0625mg

Aspen Bad

Oldesloe GmbH,

Germany

Zuellig Pharma

(B) Sdn Bhd

25 August 2016 till

24 August 2021

25 August 2021

till 24 August

2026

103 BRU11080743PLanoxin Tablet

250mcgDigoxin 250mcg

Aspen Bad

Oldesloe GmbH,

Germany

Zuellig Pharma

(B) Sdn Bhd

25 August 2016 till

24 August 2021

25 August 2021

till 24 August

2026

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104 BRU11030664PTrivastal® Retard

50 TabletPiribedil 50mg

Les Laboratoires

Servier Industrie,

France

Zuellig Pharma

(B) Sdn Bhd

26 March 2016 till

25 March 2021

26 March 2021

till 25 March

2026

105 BRU11040688PStablon Coated

Tablet 12.5mgTianeptine (as sodium) 12.5mg

Les Laboratoires

Servier Industrie,

France

Zuellig Pharma

(B) Sdn Bhd

30 April 2016 till

29 April 2021

30 April 2021 till

29 April 2026

106 BRU11040696P

Coversyl® Film-

coated Tablet

10mg

Perindopril arginine 10mg

(equiv to perindopril 6.790mg)

Les Laboratoires

Servier Industrie,

France

Zuellig Pharma

(B) Sdn Bhd

30 April 2016 till

29 April 2021

30 April 2021 till

29 April 2026

107 BRU15011738NPBactidol

MouthwashHexetidine 0.1% w/v

Interphill

Laboratories Inc.,

Philippines

LF Asia (Borneo)

Sdn Bhd

19 May 2015 till

18 May 2020

19 May 2020 till

18 May 2021