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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

line_vertical.gif (147 bytes) line1.jpg (4914 bytes) NEW indications APPROVED FOR registration

(SEPTEMBER 1998 – DECEMBER 1998)

 

No. PRODUCT THERAPEUTIC CLASS COMPANY
1. Capsule Losec 10mg [Omeprazole] Symptomatic treatment of heartburn and regurgitation in gastro-oesophageal reflux-disease (GORD) Astra Pharmaceutical (M) Sdn. Bhd.
2. Capsule Losec 20mg [Omeprazole] Treatment of NSAIDs associated peptic and gastro-duodenal erosion.

Prophylactic treatment in patients with an increased risk of NSAIDs associated peptic ulcer, gastro-duodenal erosion or dyspeptic symptoms.

Astra Pharmaceutical (M) Sdn. Bhd.
3. Controloc Gastro-Resistant Tablet 40mg [Pantoprazole] Eradication of H Pylori in peptic ulcers. Pantoprazole in combination with two other antibiotics over a period of 7 days. Mico Pharm (KL) Sdn. Bhd.