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Berita Ubat-ubatan
November 1998

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Seminar on Pharmacovigilance
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Mandatory ADR Reporting of New Chemical Entities
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Nifedipine – Induced Hypotensive Shock
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Licensing – Ten Years of Implementation
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Stage I Application Form Amended (434.1)
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Comparative Dissolution Performance of Locally Available Piroxicam Products
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Clinical Trials
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New Chemical Entity Approved For Marketing In Malaysia
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New Indications Approved For Registration
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International Visitors and Delegation
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NPCB – Contact Person

 

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Clinical Trials
(SEPTEMBER 1998 – DECEMBER 1998)

The Malaysia Drug Control Authority (DCA) has approved clinical trials licience to import ( ) unregistered products for Clinical Trials.

No. topic PLACE OF TRIALS SPONSOR
1. A multicenter study to evaluate the safety and tolerability of Tirofiban in Patients Undergoing Intracoronary Stent placement. 1. Institut Jantung Negara (IJN)

2. Hospital Universiti

Merck, Sharp & Dohme
2. A double-blind placebo controlled clinical end-points trial of Lamivudine in patients with Hepatitis B related cirrhosis. 1. Hospital Kuala Lumpur2. Hospital Queen Elizabeth, Kota Kinabalu

3. Hospital Universiti

Glaxo-Wellcome (M) Sdn. Bhd.
3. A multicenter, randomised, double-blind, double dummy, parallel group study to establish equivalance of Beclamethasone Diproprionate 500µg bd via the reservoir powder inhalation device (RPID) with Beclomethasone Diproprionate 2 x 250µg bd via the metered dose inhaler (MDI) (PBKD870481A) over 12 weeka in adolescents and adults with asthma. 1. Hospital Kuala Lumpur

2. Hospital Sultanah Aminah, Johor Bahru

3. Hospital Queen Elizabeth, Kota Kinabalu

4. Hospital USM

Glaxo-Wellcome (M) Sdn. Bhd.
4. To demonstrate the efficacy and safety of Labucavir 200mg QD in comparison with placebo in subjects with chronic Hepatitis B infection. 1. Department of Medicine, Hospital Universiti

2. Department of Medicine, Hospital Kuala Lumpur

Bristol-Myers Squibb (M) Sdn. Bhd.