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