Berita Ubat-Ubatan

Berita Ubat-ubatan
August 2000

Regulatory Control Beyond 2000

Separate Manufacturing Facilities For Cephalosporins

Warning Label for products - NSAID

Registration of Products Containing Insect Repellants

Warning for Products containing Hydroquinone

Actions To Be Taken Against Products Containing CISAPRIDE (PREPULSID)
Licensing Update - June 2000

The Changing Pharmaceutical and Traditional Medicine Premises Landscape: 1987 - 2000

Additional Indications Approved for Registered Products

GMP News

Quality Control Training Course

Sources of products registered with DCA As At 30.6.2000

New Products Approved for Marketing in Malaysia

NPCB officers to contact

Clinical Trials

NEW PRODUCTS APPROVED FOR MARKETING IN MALAYSIA
(February-May 2000)

NO.	PRODUCT	ACTIVE INGREDIENT	PRODUCT REGISTRATION HOLDER
1.	Co-Diovan Tab	Valsartan 80 Mg Hydrochlorothiazide 12.5 mg	Novartis Corp. (M) S/B
2.	Fosamax 5 Mg Tablet	Alendronate Sodium 6.53 mg equivalent to 5 mg of Alendronate free acid	Merck Sharp & Dohme (I.A) Corp.
3.	Telfast 60 Mg Capsule	Fexofenadine HCl 60.0 mg	AgrEvo H.S. (M) S/B
4.	Maxalt Tablet 5 Mg	Rizatriptan Benzoate 7.265 mg	Merck Sharp & Dohme (I.A) Corp.
5.	Maxalt Tablet 10 Mg	Rizatriptan Benzoate 14.530 mg	Merck Sharp & Dohme (I.A) Corp.
6.	Maxalt Melt 15 Mg	Rizatriptan Benzoate 7.265 mg	Merck Sharp & Dohme (I.A) Corp.
7.	Maxalt Melt 10 Mg	Rizatriptan Benzoate 14.53 mg	Merck Sharp & Dohme (I.A) Corp.
8.	Okacine Eye Drops 5.0 Ml	Lomefloxacin 3 mg (as Hydrochloride 3.31 mg)	Novartis Corp. (M) S/B
9.	Regranex Gel 0.01%	Becaplermin 0.01%	Johnson & Johnson S/B
10.	Syscor CC – 10 Mg Tablet	Nisoldipine	Zeneca Pharma (M) S/B
11.	Syscor CC – 20 Mg Tablet	Nisoldipine	Zeneca Pharma (M) S/B
12.	Syscor CC – 30 Mg Tablet	Nisoldipine	Zeneca Pharma (M) S/B
13.	Syscor CC – 40 Mg Tablet	Nisoldipine	Zeneca Pharma (M) S/B
14.	Vioxx Tablet 12.5 Mg	Rofecoxib	Merck Sharp & Dohme (I.A) Corp
15.	Vioxx Tablet 25 Mg	Rofecoxib	Merck Sharp & Dohme (I.A) Corp
16.	Vioxx Oral Suspension 12.5 Mg/5 Ml	Rofecoxib	Merck Sharp & Dohme (I.A) Corp
17.	Vioxx Oral Suspension 25 Mg/5 Ml	Rofecoxib	Merck Sharp & Dohme (I.A) Corp
18.	Sifrol Tablet 0.125 Mg	Pramipexole Dihydrochloride Monohydrate	Boehringer Ingelheim (Malaysia) S/B
19.	Sifrol Tablet 0.25 Mg	Pramipexole Dihydrochloride Monohydrate	Boehringer Ingelheim (Malaysia) S/B
20.	Sifrol Tablet 1.0 Mg	Pramipexole Dihydrochloride Monohydrate	Boehringer Ingelheim (Malaysia) S/B
21.	Fragmin 10,000 IU/ML 1 ml Ampoule	Dalteparin Sodium	Zuellig Pharma S/B
22.	Fragmin 2,500 IU/ML 4 ml Ampoule	Dalteparin Sodium	Zuellig Pharma S/B
23.	Fragmin 2,500 IU/0.2 ML Single Dose Syringe	Dalteparin Sodium	Zuellig Pharma S/B
24.	Fragmin 5,500 IU/0.2 ML Single Dose Syringe	Dalteparin Sodium	Zuellig Pharma S/B
25.	Novo Norm 0.5 Mg Tablet	Repaglinide 0.5 mg	Novo Nordisk Pharma S/B
26.	Novo Norm 1 Mg Tablet	Repaglinide 1.0 mg	Novo Nordisk Pharma S/B
27.	Novo Norm 2.0 Mg Tablet	Repaglinide 2.0 mg	Novo Nordisk Pharma S/B
28.	Nasonex Aqueous Nasal Spray	Mometasone Furoate Monohydrate	Schering-Plough S/B
29.	Zalain Cream	Sertaconazole Nitrate 2 G	Wellmex S/B
30.	Mycospor Shampoo	Bifonazole	Bayer Malaysia S/B
31.	Alpagan Ophtalmic Solution 0.2%	Brimonidine Tartrate 0.2% W/V	Diethelm (M) S/B
32.	Ziagen Oral Solution	Abacavir Sulfate 23.4 mg	Allen & Hansbury S/B
33.	Ziagen Tablet	Abacavir Sulfate 300 mg	Allen & Hansbury S/B
34.	Telebrix 30 Meglumine 30 Ml (300 mg I/ml)	Meglumine Ioxitalamate 0.66 g/ml	Ken-Med Sdn. Bhd.
35.	Telebrix 30 Meglumine 100 Ml	Meglumine Ioxitalamate 0.66 g/ml	Ken-Med Sdn. Bhd.
36.	Rebif 3 MIU/vial	Human Beta-Recombinant – 1a (11 mcg)	Antah Pharma S/B