33RD BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Traditional...33RD BRUNEI DARUSSALAM...

33RD BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MEETING LAMPIRAN D

Application ref. No.

()/DRU/DRA.Renew

al/2019

1. 316BRU10080534PS1 &

BRU10080534PS2 Fosamax 70mg Tablet

Alendronate sodium 91.37 (as

Trihydrate) equivalent to

Alendronic Acid 70mg

Merck Sharp & Dohme (Italia) SpA, Italy

(S1); Aesica Pharmaceuticals GmbH,

Germany (S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

2. 331 BRU10020407P Perinace Tablet 4mg Perindopril Erbumine 4mgUpha Pharmaceuticals Mfg (M) Sdn Bhd,

MalaysiaK-Seri Pharma Sdn Bhd

06 October 2015 till 05

October 2020POM

3. 332 BRU09100347PSCMC Plus Syrup

250mg/5mL

S-carboxy-methylcysteine

250mg/5mL (Carbocisteine)

Upha Pharmaceuticals Mfg (M) Sdn Bhd,



October 2020POM

4. 333BRU10120613PS1;

BRU10120613PS2

Esmeron® Injection

50mg/5ml (10mg/ml)Rocuronium Bromide 50mg/5ml

N.V. Organon, The Netherlands; Hameln

Pharmaceuticals GmbH, GermanyZuellig Pharma (B) Sdn Bhd

29 December 2015 till

28 December 2020POM

5. 334 BRU10100569PFosamax Plus 70/2800mcg

Tablets

Alendronic (as sodium 91.37) acid

70mg & (Vitamin D3 100,000 IU/g)

Cholecalciferol 2800mcg

Frosst iberica, S.A., Spain Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27

October 2020POM

6. 335 BRU09020208P Beprogel Topical SolutionBetamethasone (as Dipropionate

0.064%) 0.05% w/wHOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co


October 2020POM

7. 336 BRU08080108P Beprogent Cream

Betamethasone (as Dipropionate)

0.05% & Gentamicin (as Sulphate

0.1%)

Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company06 October 2015 till 05

October 2020POM

8. 337 BRU08070095P Beprogent OintmentBetamethasone 0.05% &

Gentamicin 0.1%Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020POM

9. 338 BRU08120177P Beprosalic LotionBetamethasone (as Dipropionate)

0.05% & Salicylic Acid 2.0%Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company


October 2020POM

10. 339 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine Maleate 4mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company


October 2020P

11. 340 BRU10060487P Asmol SyrupSalbutamol 2mg/5ml (as Sulphate

2.4mg)

Sunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company


October 2020POM

12. 341 BRU10040459P Atenolol 50mg Tablet Atenolol 50mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company


October 2020POM

Validity of the licenceNo. Product Registration no. Product Name Active Ingredients Manufacturer

AGENDA 4.4 - RENEWAL OF PRODUCT LICENCE OF REGISTERED MEDICINAL PRODUCTS IN THE 142, 143 & 144TH DRC MEETING

The following have been evaluated and were found to be satisfactory, and recommended by the Drug Registration Committee for endorsement by the BDMCA for registration.

142 DRC Meeting (133 Applications)

Licence HolderProduct

Classification

Agenda 4.4 / 33RD BDMCA - Renewal PL of Registered MP 0120 1


13. 342 BRU15021768P Exelon Patch 15Rivastigmine Base 27mg / 15cm2 (In

vivo release rate 13.3mg/24h)

LTS Lohmann Therapie-Systeme AG,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

14. 343 BRU09020207P Beprosalic Ointment

Betamethasone (as Dipropionate

0.064%) 0.05% & Salicylic Acid 3%

w/w

HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co06 October 2015 till 05

October 2020POM

15. 344 BRU09030225P Beprosone CreamBetamethasone (as Dipropionate



October 2020POM

16. 345 BRU09030224P Beprosone OintmentBetamethasone (as Dipropionate



October 2020POM

17. 346 BRU08090121P Candacort CreamClotrimazole 1.0% w/w &

Hydrocortisone 1.0% w/wHoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020P

18. 347 BRU08080106P Candazole Cream Clotrimazole 1.0% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company06 October 2015 till 05

October 2020GSL

19. 348 BRU08100142P Candazole Lotion Clotrimazole 1% w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company06 October 2015 till 05

October 2020GSL

20. 349 BRU10040444NP Cartril-S 500mg Capsule

Glucosamine HCl 472.5mg

equivalent to Glucosamine content

in Glucosamine Sulphate 500mg

Upha Pharmaceuticals Mfg (M) Sdn Bhd,



October 2020GSL

21. 350 BRU08120170PHydrocortisone Cream 1%

w/wHydrocortisone Acetate BP 1%w/w

Upha Pharmaceutical Mfg (M) Sdn Bhd,



October 2020P

22. 351 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mgMSD International GmbH (Puerto Rico

Branch) LLC., Puerto Rico, USA.Zuellig Pharma (B) Sdn Bhd


October 2020POM

23. 352 BRU15071902PAlendronate Sandoz 70mg

FCTAlendronic Acid 70mg Lek Pharmaceuticals D.D., Ljubljana Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

24. 353 BRU15061892P Perindosyl 4mg TabletPerindopril Tert-Butylamine 4mg

(eqv. to 3.338mg Perindopril)Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd

28 July 2015 till 27 July

2020POM

25. 354 BRU10120599PS2 JanuviaTM Tablet 25mg Sitagliptin (as Phosphate) 25mg Merck Sharp & Dohme Ltd, England (S2) Zuellig Pharma (B) Sdn Bhd29 December 2015 till

28 December 2020POM

26. 355 BRU10110581PS2 JanuviaTM Tablet 50mg Sitagliptin (as Phosphate) 50mg Merck Sharp & Dohme Ltd, England (S2) Zuellig Pharma (B) Sdn Bhd24 November 2015 till

23 November 2020POM

27. 356 BRU10100560PS2Arcoxia 60mg Film-Coated

TabletEtoricoxib 60mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd


October 2020POM

28. 357 BRU10110582PS2 Arcoxia® 90mg Tablet Etrocoxib 90mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd24 November 2015 till

23 November 2020POM

29. 358 BRU10100566PS2 Arcoxia 120mg Tablet Etoricoxib 120mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27

October 2020POM

30. 359 BRU10120602POrgalutron Solution For

Injection 0.25mg/0.5mlGanirelix Acetate 0.25mg/0.5ml

Vetter Pharma-Fertigung GmbH & Co. KG,



28 December 2020POM



31. 360 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg

Aspen Port Elizabeth (Pty) Ltd,

Republic of South Africa Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

32. 361 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mg

Aspen Port Elizabeth (Pty) Ltd,

Republic of South Africa Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

33. 362 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mgSunward Pharmaceutical Pte Ltd,



October 2020POM

34. 363 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mgSunward Pharmaceutical Sdn. Bhd.,



October 2020POM

35. 364 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mgSunward Pharmaceutical Pte Ltd,



October 2020POM

36. 365 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mgSunward Pharmaceutical Pte Ltd,



October 2020POM

37. 366 BRU09080309P Fenagesic Capsule 250mg Mefenamic Acid 250mgSunward Pharmaceutical Pte Ltd,



October 2020POM

38. 367 BRU09070282PHydrocortisone Cream 1%

w/wHydrocortisone Acetate 1%w/w

Sunward Pharmaceutical Sdn Bhd,



October 2020P

39. 368 BRU14111591PPristiq 50mg Extended-

Release Tablets

Desvenlafaxine 50mg (as Succinate

75.87mg)Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd


2020POM

40. 369 BRU15031814PNimenrixTM (Meningococcal

polysaccharide serogroups

A,C,W-135, Y) Vaccine

MenAAH-TT-conjugate (Mean TT/PS

ratio:3) 5mcg PSA~15mcg TT,

MenCAH-TT-conjugate (Mean TT/PS

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

MenW-TT-conjugate (Mean TT/PS

ratio:1.5) 5mcg PSW~7.5mcg TT,

MenY-TT-conjugate (Mean TT/PS

ratio:1.3) 5mcg PSY~6.5mcg TT

Glaxosmithkline Biologicals s.a., Rixensart,

Belgium; GlaxoSmithKline Biologicals,

Branch of SmithKline Beecham Pharma

GmbH & Co. KG., Dresden

Germany (diluent Ampoule); Delpharm

Tours, Chambray-lès-Tours

France (Diluent ampoule);

GlaxoSmithKline Biologicals SA, Rixensart

Belgium (diluent PFS); Catalent Belgium

SA, Brussels, Belgium (diluent PFS);

GlaxoSmithKline Biologicals S.A. , Wavre

Belgium (Additional facility for

formulation); Pfizer Manufacturing

Belgium NV, Belgium (additional

secondary packaging site)

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020POM

41. 370 BRU15021784PToviaz 4mg Prolonged-

Release Tablet

Fesoterodine Fumarate equivalent

to 3.1mg FesoterodineAesica Pharmaceuticals GmbH, Germany Zuellig Pharma (B) Sdn Bhd


2020POM

42. 371 BRU15021785PToviaz 8mg Prolonged-

Release Tablet

Fesoterodine Fumarate equivalent

to 6.2mg FesoterodineAesica Pharmaceuticals GmbH, Germany Zuellig Pharma (B) Sdn Bhd


2020POM



43. 372 BRU14111589PResolor Film-Coated Tablet

1mg

Prucalopride 1mg (as Succinate

1.321mg)Janssen-Cilag SpA., Italy Zuellig Pharma (B) Sdn Bhd


2020POM

44. 373 BRU15071904PResolor Film-Coated Tablet

2mg

Prucalopride Succinate 2.642mg

equivalent to Prucalopride 2mgJanssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd


2020POM

45. 374 BRU14111650PInvokana Film-Coated

Tablet 100mg

Canagliflozin 100mg (as

Hemihydrate)

JANSSEN ORTHO, LLC, Puerto Rico, USA

[Repacker: Janssen-Cilag SpA, Italy]Zuellig Pharma (B) Sdn Bhd


2020POM

46. 375 BRU14121699PInvokana 300mg Film-

Coated Tablet

Canagliflozin 300mg (as

Hemihydrate)

JANSSEN ORTHO, LLC, Puerto Rico, USA

[Repacker: Janssen-Cilag SpA, Italy]Zuellig Pharma (B) Sdn Bhd


2020POM

47. 376 BRU14121698PEdurant Film-Coated 25mg

tabletRilpivirine (as Hydrochloride) 25mg Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd


2020POM

48. 377 BRU15021757P

Simponi Solution for

Injection In Pre-Filled

Syringe 50mg/0.5ml

Golimumab 50mg/0.5mlBaxter Pharmaceutical Solutions LLC, USA

(Repacker - Cilag AG, Switzerland)Zuellig Pharma (B) Sdn Bhd


2020POM

49. 378 BRU08030023P Augmentin Tablet 625mg

Amoxycillin 500mg (as Trihydrate)

& Clavulanic Acid 125mg (as

Potassium Clavulanate)

SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

50. 379 BRU07100002P Augmentin Injection 600mg

Co-Amoxiclav 500/100 - Amoxicillin

500mg as Sodium Salt & Clavulanic

Acid 100mg as Potassium Salt

SmithKline Beecham PLC, Worthing, West

Sussex, UKZuellig Pharma (B) Sdn Bhd


October 2020POM

51. 380 BRU07100001P Augmentin Injection 1.2g

Co-Amoxiclav 1000/200 -

Amoxicillin 1g as Sodium Salt,

Clavulanic Acid 200mg as Potassium

Salt

SmithKline Beecham PLC, Worthing, West

Sussex, UKZuellig Pharma (B) Sdn Bhd


October 2020POM

52. 382 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

53. 383 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mgGlaxoSmithKline Australia Pty Ltd,

AustraliaZuellig Pharma (B) Sdn Bhd


October 2020POM

54. 384 BRU08030034P Zinacef Injection 750mg Cefuroxime (as Sodium) 750mg GlaxoSmithKline Manufacturing SPA, Italy. Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

55. 385 BRU08040041P Zeffix Tablet Lamivudine 100mgGlaxoSmithKline Pharmaceuticals S.A.,

Poland Zuellig Pharma (B) Sdn Bhd


October 2020POM

56. 386 BRU08070090PZinnat Suspension

125mg/5ml

Cefuroxime Axetil equivalent to

Cefuroxime 250mg

Glaxo Wellcome Operations, Bernard

Castle, United KingdomZuellig Pharma (B) Sdn Bhd


October 2020POM

57. 387 BRU08040042P Combivir TabletLamivudine 100mg & Zidovudine

300mg

GlaxoSmithKline Pharmaceuticals S.A.,

PolandZuellig Pharma (B) Sdn Bhd


October 2020POM

58. 388 BRU13121183P Anarex TabletsParacetamol 450mg &

Orphenadrine Citrate 35mg

Beacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co


29 December 2018

(pending renewal

submission)

P

59. 389 BRU09080308PAtrovent N 20µg/Puff

Metered Dose Inhaler

Ipratropium Bromide Anyhdrous

20mcg (as Monohydrate 21mcg)

Boehringer Ingelheim Pharma GmbH &

Co. KG, Germany

Hongkiat Trading &

Company


October 2020POM



60. 390 BRU09040244P Cloderm CreamClobetasone (as Butyrate)

0.05%w/wHOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co


October 2020POM

61. 391 BRU09100331P Cloderm OintmentClobetasol (as Propionate)

0.05%w/wHOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading Company


October 2020POM

62. 392 BRU09020209P Cloderm Scalp ApplicationClobetasol (as Dipropionate) 0.05%

w/vHOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co


October 2020POM

63. 393 BRU09020210P Declovir Cream Acyclovir 5.0% w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co06 October 2015 till 05

October 2020P

64. 394 BRU08090119P Decocort CreamMiconazole Nitrate 2%w/w &

Hydrocortisone 1% w/wHoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020P

65. 395 BRU08100134P Decozol Cream Miconazole Nitrate 2% w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company06 October 2015 till 05

October 2020GSL

66. 396 BRU10060497P Hyosun Syrup

Hyoscine-N-Butylbromide

(Scopolamine Butylbromide)

5mg/5ml

Sunward Pharmaceutical Pte. Ltd.,



October 2020POM

67. 397 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mgSunward Pharmaceutical Pte. Ltd.,



October 2020

GSL (6's) & P

(60's)

68. 398 BRU09050258P Lobesol CreamClobetasol (as Propionate)

0.05%w/w




October 2020POM

69. 399 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mgSunward Pharmaceutical Pte Ltd,



October 2020POM

70. 400 BRU10110587PMetoclopramide Syrup

5mg/5ml

Metoclopramide Hydrochloride

5mg/5ml

Sunward Pharmaceutical Pte Ltd,


24 November 2015 till

23 November 2020POM

71. 401 BRU10070512PMetoclopramide Tablet

10mgMetoclopramide HCl 10mg




October 2020POM

72. 402 BRU10090552PHarnal OCAS 400mcg Film-

Coated Tablet

Tamsulosin (as Hydrochloride

400mcg) 367mcg

Astellas Pharma Europe BV, The

NetherlandsMedipharm Sdn Bhd


October 2020POM

73. 403 BRU10080523P Exforge 10/160mg FC TabletAmlodipine 10mg (as Besylate) &

Valsartan 160mg

Novartis Farmaceutica SA, Barbera del

Valles

(Barcelona) SpainZuellig Pharma (B) Sdn Bhd


October 2020POM

74. 404 BRU10010388P Exforge Tablet 5mg/160mgAmlodipine 5mg (as Besylate

6.94mg) & Valsartan 160mgNovartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd


October 2020POM

75. 405 BRU09090329P Exforge Tablet 5mg/80mgAmlodipine 5mg (as Besylate

6.94mg) & Valsartan 80mgNovartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd


October 2020POM

76. 406 BRU10100563P Exelon® Patch 5 Rivastigmine Base 9mg/5cm2

(4.6mg/24 hours)

LTS Lohmann Theraphie-System AG,



October 2020POM

77. 407 BRU10040462PExelon Oral Solution

2mg/ml

Rivastigmine 2mg/ml (as Hydrogen

Tartrate)Delpharm Huningue SAS, France Zuellig Pharma (B) Sdn Bhd


October 2020POM

78. 408 BRU10060499P Exelon Capsule 1.5mgRivastigmine 1.5mg (as Hydrogen

Tartrate 2.4mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd


October 2020POM

79. 409 BRU10070520P Exelon® 4.5mg Capsule

Rivastigmine 4.5mg (as

Rivastigmine Hydrogen Tartrate

7.2mg)

Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM



80. 410 BRU10060501P Exelon Capsule 6mgRivastigmine 6mg (as Hydrogen

Tartrate 9.6mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd


October 2020POM

81. 411 BRU08050073P Dezor Cream Ketoconazole 2% w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company06 October 2015 till 05

October 2020GSL

82. 412 BRU08050074P Dezor Shampoo Ketoconazole 2% w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company06 October 2015 till 05

October 2020GSL

83. 413 BRU08070094P Ecocort CreamEconazole Nitrate 1% w/w &

Triamcinolone Acetonide 0.1% w/wHoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020POM

84. 414 BRU08030027P Foban Cream Fusidic Acid 2% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company06 October 2015 till 05

October 2020POM

85. 415 BRU08060086P Foban Hydro CreamFusidic Acid 2% & Hydrocortisone

1%Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020POM

86. 416 BRU08060087P Foban Hydro OintmentSodium Fusidate 2% &

Hydrocortisone 1%Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020POM

87. 417 BRU08030024PAugmentin Syrup

228mg/5ml

Amoxycillin 200mg/5ml (as

Trihydrate) & Clavulanic Acid

28.5mg/5ml (as Potassium

Clavulanate)


October 2020POM

88. 418 BRU08030025PAugmentin Syrup

457mg/5ml

Amoxycillin 400mg/5ml (as

Trihydrate) & Clavulanic Acid

57mg/5ml (as Potassium

Clavulanate)


October 2020POM

89. 419 BRU08110152PZovirax IV For Infusion

250mgAciclovir 250mg GlaxoSmithKline Manufacturing SPA Italy Zuellig Pharma (B) Sdn Bhd


October 2020POM

90. 420 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as Axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

91. 421 BRU08020020P

Diprivan 10mg/ml (1%)

Emulsion For Injection Or

Infusion (20ml Ampoule)

Propofol 10mg/ml (1%) Corden Pharma S.P.A, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

92. 422 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

93. 423 BRU08040040P Retrovir Syrup Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

94. 424 BRU10060498P Nalol Tablet 40mg Propranolol HCl 40mgSunward Pharmaceutical Pte. Ltd.,



October 2020POM

95. 425 BRU10070511P Decondine TabletTripolidine HCl 2.5mg &

Pseudoephedrine HCl 60mg




October 2020POM

96. 426 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mgSunward Pharmaceutical Pte Ltd,



October 2020P (100x10's)

97. 427 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine Maleate 2mgSunward Pharmaceutical Sdn Bhd,



October 2020POM

98. 428 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical Sdn Bhd,

Malaysia.G & H Trading Company


October 2020POM



99. 429 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HClSunward Pharmaceutical Sdn Bhd,



October 2020POM

100.

430 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mg

Novartis Saglik, Gida ve Tarim Urunleri

San. Ve Tic. A.S. Yenisehir Mahalledi,

Turkey


October 2020POM

101.

431 BRU09030219P

Cataflam 1.5% Oral Drops

SuspensionDiclofenac Sodium 15mg/ml Delpharm Huningue SAS, France Zuellig Pharma (B) Sdn Bhd


October 2020POM

102.

432 BRU10040452P Nitroderm TTS® 10

Glyceral Trinitrate / Nitroglycerin

50mg (10mg/24hr)Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd


October 2020POM

103.

433 BRU10060505P

Myfortic Gastro-Resistant

Tablet 180mg

Mycophenolic Acid 180mg (as

Sodium Salt 192.4mg)

Novartis Pharma Produktions GmbH,



October 2020POM

104.

434 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd


October 2020POM

105.

435 BRU09120381PS2

Co-Diovan 80/12.5 Film-

Coated Tablets

Valsartan 80mg &

Hydrochlorothiazide 12.5mgNovartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd


October 2020POM

106.

436 BRU10040457PS2

Co-Diovan 160/12.5mg

Tablets

Valsartan HCl 160mg &

Hydrochlorothiazide 12.5mgNovartis Pharma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd


October 2020POM

107.

437 BRU10010392PS2

Co-Diovan 160/25 Film-

Coated Tablets

Valsartan 160mg &

Hydrochlorothiazide 25mgNovartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd


October 2020POM

108.

438 BRU15041846P Vancotex Injection 500mg

Vancomycin (as Hydrochloride)

500mgFisiopharma S.r.L., Italy K-Seri Pharma Sdn. Bhd.


2020POM

109.

439 BRU10020412P Seretide Accuhaler 50/100

Salmeterol 50mcg (as Xinafoate) &

Fluticasone Propionate 100mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd


October 2020POM

110.


Salmeterol (as Xinafoate) 50mcg &



October 2020POM

111.


Salmeterol 50mcg (as Xinafoate) &



October 2020POM

112.

442 BRU09100335P

Ventolin Nebules

2.5mg/2.5mlSalbutamol Sulphate 2.5mg/2.5ml

GlaxoSmithKline Australia Pty Ltd,

AustraliaZuellig Pharma (B) Sdn Bhd


October 2020POM

113.

443 BRU10050475P

Zyrtec® Oral Solution

1mg/mlCetrizine diHCl 1mg/ml (0.1%) Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd


October 2020P

114.

444 BRU08120173P Ventolin Respirator Solution Salbutamol (as Sulphate) 0.5% w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd


October 2020POM

115.

445 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/v Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020POM

116.

446 BRU08050072P Fobancort Cream

Fusidic Acid 2% w/w &

Betamethasone Dipropionate

0.064% w/w equivalent to

Betamethasone 0.05% w/w


October 2020POM



117.

447 BRU08090120P Fobancort Ointment

Sodium Fusidate 2% w/w &

Betamethasone 0.05% w/w (as

Dipropionate 0.064%)


October 2020POM

118.

448 BRU08080107P

HOE Gentamicin Cream

0.1% w/wGentamicin (as Sulphate) 0.1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020POM

119.

449 BRU09100332P H-Cort Cream Hydrocortisone 1% w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading Company


October 2020P

120.

450 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020P

121.

451 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mg




October 2020P

122.

452 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mg


Singapore G & H Traidng Company


October 2020POM

123.

453 BRU09100346NP Suniton Tablet

Paracetamol 450mg &

Orphenadrine Citrate 35mg




October 2020P

124.

454 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mg




October 2020POM

125.

455 BRU10110588NP Suntacid Tablet

Aluminium Hydroxide 250mg,

Magnesium Trisilicate 250mg,

Simethicone 30mg




23 November 2020GSL

126.

456 BRU09060269P Zorax Cream Aciclovir 5% w/w




October 2020P

127.

457 BRU09100337P Zoloft Tablet 50mg Sertraline (as Hydrochloride) 50mg

Pfizer Manufacturing Deutschland GmbH,

Germany

(Manufacturing, packaging, testing and

release.


October 2020POM

128.

458 BRU15071903NP

Chlorhex 4% Antiseptic

SolutionChlorhexidine Gluconate 4% Pahang Pharmacy Sdn Bhd., Malaysia G & H Trading Company


2020GSL

129.

459 BRU09070281P Orrepaste 0.1% w/w Triamcinolone Acetate 0.1% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia. G & H Trading Company


October 2020P

130.

460 BRU09040243P T3 Mycin Gel Clindamycin (as Phosphate) 1.0% HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co


October 2020POM

131.

461 BRU09050257P T3 Mycin Lotion

Clindamycin (as Phosphate) 1.0%

w/vHOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020POM

132.

462 BRU09030228P U-Closone Cream Clobetasone Butyrate 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co


October 2020POM

133.

463 BRU09040246P U-Closone Ointment

Clobetasol (as Propionate)

0.05%w/wHOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading Company


October 2020POM




()/DRU/DRA.Renew

al/2019

1. 464 BRU10020411P Decondine SyrupPer 5ml - Triprolidine HCl 1.25mg;

Pseudoephedrine HCl 30mg




October 2020POM

2. 465 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1% w/wSunward Pharmaceutical Sdn Bhd



October 2020P

3. 466 BRU10020414P Sunadine Syrup Loratadine 5mg/5mlSunward Pharmaceutical Sdn Bhd,



October 2020P

4. 467 BRU09060266P Benosone CreamBetamethasone (as Valerate) 0.1%

w/wHOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company


October 2020POM

5. 468 BRU09050254P Benosone Ointment Betamethasone 0.1% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company06 October 2015 till 05

October 2020POM

6. 469 BRU09050253P Benosone-N Ointment

Betamethasone (as Valerate 0.12%

w/w) 0.1% w/w & Neomycin

Sulphate 0.50% w/w

HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company06 October 2015 till 05

October 2020POM

7. 470 BRU10030427P Omesec Capsule 20mg Omeprazole 20mgUpha Pharmaceuticals Mfg (M) Sdn Bhd,



October 2020POM

8. 471 BRU08060083P Eryson Granules 200

Erythromycin Ethylsuccinate

equivalent to Eryhtromycin

200mg/5ml

Upha Pharmaceutical Mfg (M) Sdn Bhd,



October 2020 POM

9. 472 BRU08090131P Beamoxy Capsule 500 Amoxicillin (as Trihydrate) 500mgUpha Pharmaceutical Mfg (M) Sdn Bhd,



October 2020POM

10. 473 BRU09120378P Chloramine Tablet 4mg Chlorpheniramine Maleate 4mgUpha Pharmaceuticals Mfg (M) Sdn Bhd,



October 2020P

11. 474 BRU08050070P Betacin Eye Ear Drop

Neomycin Sulphate 0.5% w/v &

Betamethasone Sodium Phosphate

0.1% w/v

Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd06 October 2015 till 05

October 2020POM

12. 475 BRU09060261P Beamoxy Capsule 250 Amoxycillin (as Trihydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn Bhd K-Seri Pharma Sdn Bhd06 October 2015 till 05

October 2020POM

13. 476BRU10070513PS1;

BRU10070513PS2 Desferal 500mg

Desferrioxamine Methane

Sulphonate

Wasserburger Arzneimittelwerk GmbH,

Wasserburg



October 2020POM

14. 477 BRU10010391PS2 Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

15. 478 BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

Product

ClassificationLicence Holder Validity of the licenceNo. Product Registration no. Product Name Active Ingredients Manufacturer

143 DRC Meeting (51 Applications)



16. 479 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

17. 480 BRU09060264PVoltaren 12.5mg

SuppositoriesDiclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd


October 2020POM

18. 481 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

19. 482 BRU09060265PVoltaren 50mg

SuppositoriesDiclofenac Sodium 50mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd


October 2020POM

20. 483 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg

Novartis Saglik, Gida ve Tarim Urunleri

San. Ve Tic. A.S. Yenisehir Mahalledi,

Turkey


October 2020POM

21. 484 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac Sodium 100mg Novartis Farma SpA, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

22. 485 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mg Novartis Farma S.p.A, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

23. 486 BRU09040235PVoltaren 75mg/3ml Solution

For InjectionDiclofenac Sodium 75mg/3ml Lek Pharmaceuticals d.d, Slovenia Zuellig Pharma (B) Sdn Bhd


October 2020POM

24. 487BRU09080300PS1 &

BRU09080300PS2Diamicron MR Tablet 30mg Gliclazide 30mg

Les Laboratoires Servier Industrie, France

(S1) & Kotra Pharma (M) Sdn. Bhd,

Malaysia (S2)


October 2020POM

25. 488 BRU09050249P Vastarel 20mg TabletTrimetazidine Dihydrochloride

20mgLes Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd


October 2020POM

26. 489BRU09030217PS1 &

BRU09030217PS2Vastarel MR 35mg Tablet Trimetazidine HCl 35mg

Les Laboratoires Servier Industrie, France

(S1); Kotra Pharma (M) Sdn. Bhd, Malaysia

(S2)


October 2020POM

27. 490 BRU10020418PNitroderm TTS® 5

(5mg/24hr)

Glyceryl Trinitrate/ Nitroglycerin

25mgNovartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd


October 2020POM

28. 491 BRU10090550P Ritalin LA 20mg CapsulesMethylphenidate Hydrochloride

20mgRecro Gainsville LLC, USA. Zuellig Pharma (B) Sdn Bhd


October 2020POM

29. 492 BRU10080530P Ritalin 10mg TabletMethylphenidate Hydrochloride

10mgNovartis Farmaceutica SA Spain Zuellig Pharma (B) Sdn Bhd


October 2020POM

30. 493 BRU10070522PRitalin® Modified Release

Capsule 30mgMethylphenidate HCl 30mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd


October 2020POM

31. 494 BRU14111646NPOralite Orange Oral

Rehydration Salts

Per 4.95g - Glucose Anhydrous

3.24g; Sodium Chloride 0.624g;

Trisodium Citrate Dihydrate 0.696g;

Potassium Chloride 0.36g

Royce Pharma Manufacturing Sdn. Bhd.,

Malaysia

SWL Biomed Sales &

Services


2020GSL

32. 495 BRU14111583NPOralite Natural Oral

Rehydration Salts

Per 4.92g sachet: Glucose

Anhydrous 3.24g; Sodium Chloride

0.624g; Trisodium Citrate Dihydrate

0.696g; Potassium Chloride 0.36g


Malaysia

SWL Biomed Sales &

Services


31 October 2019GSL

33. 496 BRU14121701P Borymycin Capsule 100mg Minocycline HCl 100mg Y.S.P., Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd19 May 2015 till 18 May

2020POM



34. 497 BRU14111621PBrozil Film Coated Tablet

600mgGemfibrozil 600mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd


2020POM

35. 498 BRU14111599P Cardiol Tablet 6.25mg Carvedilol 6.25mgYung Shin Pharmaceutical Ind. Co. Ltd.,

TaiwanAsterix United (B) Sdn Bhd


2020POM

36. 499 BRU15011723PClarimycin Film Coated

Tablet 250mgClarithromycin 250mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd


2020POM

37. 500 BRU14121686P Decan Injection 2mg/ml

Dexamethasone Sodium Phosphate

2.2mg (eq. to Dexamethasone

Phosphate 2mg)

Yung Shin Pharmaceutical Ind. Co., Ltd,

Taiwan, R.O.C.Asterix United (B) Sdn Bhd


2020POM

38. 501 BRU14111636P Melomet Cream 0.1% w/w Mometasone Furoate 0.1% w/w Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd19 May 2015 till 18 May

2020POM

39. 502 BRU09120376NP Poro Suppository 125mg Paracetamol 125mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05

October 2020

GSL (1 x 5's);

P(10 x 10's)

40. 503 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United Sdn Bhd06 October 2015 till 05

October 2020

GSL (1 x 5's), P

(10 x 10's)

41. 504 BRU14121690P Seladin 500mg Tablet Naproxen 500mg Y.S.P. Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd19 May 2015 till 18 May

2020POM

42. 505 BRU15011745P Seladin 250mg Tablet Naproxen 250mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd19 May 2015 till 18 May

2020POM

43. 506 BRU09060270P Nexium Mups 20mgEsomeprazole (as Magnesium

Trihydrate) 20mgAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd


October 2020POM

44. 507 BRU09070284P Nexium Mups 40mgEsomeprazole (as Magnesium

Trihydrate) 40mgAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd


October 2020POM

45. 508 BRU09040247P Nexium® IV 40mg Esomeprazole (as Sodium) 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

46. 509 BRU09010194PPulmicort Turbuhaler

100mcg/doseBudesonide 100mcg AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd


October 2020POM

47. 510 BRU09080295PPulmicort® Turbuhaler®

200mcg/dose

Budesonide (Micronised) Ph Eur

200mcg/doseAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd


October 2020POM

48. 511 BRU09020206PBricanyl Turbuhaler

0.5mg/doseTerbutaline Sulphate 0.5mg/dose

AstraZeneca Dunkerque Production,

FranceZuellig Pharma (B) Sdn Bhd


October 2020POM

49. 512 BRU15071911PHydrogen Peroxide Solution

(6%)

Hydrogen Peroxide 6% w/v

(equivalent to 20 volumes of

available oxygen)

The Government Pharmaceutical

Organization, Thailand

SWL Biomed Sales &

Services


2020GSL

50. 513 BRU15051873NP Calamine Lotion Calamine BP 15% w/vRoyce Pharma Manufacturing Sdn Bhd,

Malaysia

SWL Biomed Sales &

Services


2020GSL

51. 514 BRU15061883NPPovidone Iodine Solution

10% w/vPovidone Iodine 10% w/v


Malaysia

SWL Biomed Sales &

Services


2020GSL




()/DRU/DRA.Renew

al/2019

1. 381 BRU09030213P 3TC Tablet 150mg Lamivudine 150mgGlaxoSmithKline Pharmaceuticals S.A.,

PolandZuellig Pharma (B) Sdn Bhd


October 2020POM

2. 515 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

3. 516 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

4. 517 BRU10110596PBeconase™ Aqueous Nasal

Spray

Beclomethasone Dipropionate (as

Monohydrate)Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd


23 November 2020POM

5. 518 BRU09010187PSymbicort Turbuhaler

160/4.5mcg Dose

Budenoside 160mcg; Formoterol

Fumarate Dihydrate 4.5mcgAstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd


October 2020POM

6. 519 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM


October 2020POM


October 2020POM

9. 522 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27

October 2020POM

10. 523 BRU10110590P Zoladex Depot 3.6mg/Dose Goserelin (as Acetate) 3.6mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd24 November 2015 till

23 November 2020POM

11. 524 BRU09110353P Tenoretic TabletAtenolol 100mg; Chlorthalidone

25mgAstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd


October 2020POM

12. 525 BRU15091935P Cardiprin 100 Tablet Aspirin 100mgReckitt Benckiser Healthcare (UK),United

KingdomZuellig Pharma (B) Sdn Bhd


2020POM

13. 526 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

14. 527 BRU10030432PCisplatin CS Injection

50mg/50mlCisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd


October 2020POM

15. 528 BRU10030435PAdriamycin CS Injection

50mg/25mlDoxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd


October 2020POM

16. 529 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mgRecipharm Uppsala AB, Bjorkgatan 30, SE-

751 82 Uppsala, Sweden.Zuellig Pharma (B) Sdn Bhd


October 2020POM

17. 530 BRU15111965PAxcel Betamethasone

Cream

Betamethasone 17-Valerate

(micronized) equivalent to

Betamethasone 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec

2020POM

Product

ClassificationLicence Holder Validity of the licence

144 DRC Meeting (56 Applicaitons)

No. Product Registration no. Product Name Active Ingredients Manufacturer



18. 531 BRU08120168PAxcel Cephalexin 125mg

Suspension

Cephalexin (as Monohydrate)

125mgKotra Pharma (M) Sdn Bhd Malaysia Medicorp Sdn Bhd


October 2020

POM (60ml &

100ml)

19. 532 BRU08120167PAxcel Cephalexin 250mg

Caspule


250mgKotra Pharma (M) Sdn Bhd Malaysia Medicorp Sdn Bhd


October 2020POM

20. 533 BRU08110155PAxcel Cephalexin-500

Capsule


500mgKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd


October 2020POM

21. 534 BRU15091939NP Hoe Zinc Cream Zinc Oxide 32% w/w HOE Pharmaceuticals Sdn. Bhd., Malaysia G & H Trading Company09 Dec 2015 till 08 Dec

2020GSL

22. 535 BRU15111958P A Scabs Lotion Permethrin 5.0% w/v HOE Pharmaceuticals Sdn. Bhd., Malaysia G & H Trading Company09 Dec 2015 till 08 Dec

2020GSL

23. 536 BRU10030430PPharmorubicin CS

50mg/25mlEpirubicin HCl 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd


October 2020POM

24. 537 BRU10020410PEtoposide CS 100mg/5ml

InjectionEtoposide 100mg/5ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd


October 2020POM

25. 538 BRU10030433PTerramycin Ophthalmic

Ointment

Per g - Oxytetracycline 5mg;

Polymyxin B 10,000units PT Pfizer (Indonesia), Indonesia Zuellig Pharma (B) Sdn Bhd


October 2020POM

26. 539 BRU15091930PZymar (Gatifloxacin

Ophthalmic Solution) 0.3%Gatifloxacin 0.3% Allergan Sales LLC, United States MediPharm Sdn Bhd


2020POM

27. 540 BRU11010619PS2 JanuviaTM Tablet 100mg Sitagliptin (as Phosphate) 100mg Merck Sharp & Dohme Ltd, England (S2) Zuellig Pharma (B) Sdn Bhd26 January 2016 till 25

January 2021POM

28. 541 BRU11010624P Elomet Ointment 0.1%Mometasone Furoate (as

Anhydrous) USP 0.1%

PT. Merck Sharp Dohme Pharma Tbk,

IndonesiaZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

29. 542 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd06 October 2015 till 05

October 2020GSL

30. 543 BRU08090127P Axcel Fusidic Acid Ointment Sodium Fusidate 2% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd06 October 2015 till 05

October 2020POM

31. 544 BRU08110156PAxcel Eryhthromycin ES-200

Suspension

Erythromycin (as Ethylsuccinate)

200mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd


October 2020POM

32. 545 BRU08090126P Axcel Fusidic Cream Fusidic Acid 2% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd06 October 2015 till 05

October 2020POM

33. 546 BRU08080117P Axcel Fusidic Acid-B CreamFusidic acid 2%, Betamethasone (as

17-valerate) 0.1%Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd


October 2020POM

34. 547 BRU08110153PAxcel Aciclovir Cream 5%

w/wAciclovir 5% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd


October 2020P

35. 548 BRU09040230PAxcel Cefuroxime-250

CapsuleCefuroxime (as Axetil) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd


October 2020POM

36. 549 BRU09060259PVaxcel Cefuroxime 1.5g

InjectionCefuroxime (as Sodium) 1.5g Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd


October 2020POM

37. 550 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as Pentahydrate) 2g Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd06 October 2015 till 05

October 2020POM

38. 551 BRU15101956PPred Forte Sterile

Ophthalmic Suspension 1%Prednisolone Acetate 1% w/v

Allergan Pharmaceuticals Ireland, Mayo,

IrelandMedipharm Sdn Bhd


2020POM



39. 552 BRU15091928PAcular Ophthalmic Solution

0.5%Ketorolac Tromethamine 0.5% Allergan Pharmaceuticals Ireland, Ireland MediPharm Sdn Bhd


2020POM

40. 553 BRU14111586PZyvox 20mg/ml Granules

For Oral SuspensionLinezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USA Zuellig Pharma (B) Sdn Bhd


2020POM

41. 554 BRU10050471PZyvox Infusion Bag

600mg/300mlLinezolid 600mg/300ml Fresenius Kabi Norge As, Norway Zuellig Pharma (B) Sdn Bhd


October 2020POM

42. 555 BRU10060502PZyvox Film-Coated Tablet

600mgLinezolid 600mg

Pfizer Pharmaceuticals LLC, Puerto Rico,

United StatesZuellig Pharma (B) Sdn Bhd


October 2020POM

43. 556 BRU10120615PFlixotideTM EvohalerTM

125mcgFluticasone Propionate 125mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd


28 December 2020POM

44. 558 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mgAstellas Pharma Europe B.V., The

NetherlandsMedipharm Sdn Bhd


28 December 2020POM

45. 559 BRU10100562P Exelon® Patch 10Rivastigmine Base 18mg / 10cm2

(9.5mg/24h)

LTS Lohmann Theraphie-System AG,



October 2020POM

46. 560 BRU10100559P Exelon® Capsule 3mgRivastigmine (as Hydrogen Tartrate)

3mgNovartis Farmaceutica S.A. Spain Zuellig Pharma (B) Sdn Bhd


October 2020POM

47. 561 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

48. 562 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

49. 563 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV, Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

50. 564 BRU08040049PDiflucan IV Infusion 2mg/ml

(50ml)Fluconazole 2mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd


October 2020POM

51. 568 BRU10090551PZoladex LA Depot Injection

10.8mg

Goserelin Acetate equivalent to

Goserelin 10.8mgAstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd


October 2020POM

52. 569 BRU15011727P Bactigen Eye Drops 0.3%Gentamicin 0.3% (as Gentamicin

Sulphate)FDC Limited, India K-Seri Pharma Sdn Bhd


2020POM

53. 570 BRU10100568PZithromax Powder For Oral

Suspension 200mg/5ml

Azithromycin (as Dihydrate)

200mg/5mlHaupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd


October 2020POM

54. 571 BRU10070519P Zithromax IV 500mg Azithromycin (as Dihydrate) 500mgPharmacia & Upjohn Company,

Kalamazoo, USAZuellig Pharma (B) Sdn Bhd


October 2020POM

55. 572 BRU08120180PZithromax Film-Coated

Tablet 250mgAzithromycin (as Dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd


October 2020POM

56. 573 BRU11010635PZantac SyrupTM

150mg/10ml

Ranitidine (as Hydrochloride)

150mg/10mlAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM


33RD BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Traditional...33RD BRUNEI DARUSSALAM...

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BRUNEI DARUSSALAM[1]

Document1 - Universiti Brunei Darussalam

ANNEX I SCHEDULE OF BRUNEI DARUSSALAM … OF BRUNEI DARUSSALAM INTRODUCTORY NOTES ... Brunei Darussalam, ... Procedures of Contractors and Suppliers Registration,

Universiti Brunei Darussalam Brunei Darussalam

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