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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 CHEMICAL ENTITY APPROVED FOR MARKETING IN MALAYSIA
(SEPTEMBER 1998 – DECEMBER 1998)

 

No. PRODUCT THERAPEUTIC CLASS COMPANY
1. Rilutek Tablet [Riluzole 50mg] Others (Neuroprotective) Rhone-Poulene (M) Sdn. Bhd.
2. Zyprexa 5mg Tablet [Olanzapine] For the acute and maintenance treatment of schizophrenia and other psychoses where positive symptom (e.g., delusions, hallcinations, disordered thinking, hostility and suspiciousness) and/or negative symptoms (e.g., flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Olanzapine is effective in maintaining the clinical improvement during continuing therapy in patients who have shown initial treatment response. Eli Lilly (M) Sdn. Bhd.
3. Zyprexa 7.5mg Tablet [Olanzapine] For the acute and maintenance treatment of schizophrenia and other psychoses where positive symptom (e.g., delusions, hallcinations, disordered thinking, hostility and suspiciousness) and/or negative symptoms (e.g., flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Olanzapine is effective in maintaining the clinical improvement during continuing therapy in patients who have shown initial treatment response. Eli Lilly (M) Sdn. Bhd.
4. Zyprexa 10mg Tablet [Olanzapine] For the acute and maintenance treatment of schizophrenia and other psychoses where positive symptom (e.g., delusions, hallcinations, disordered thinking, hostility and suspiciousness) and/or negative symptoms (e.g., flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Olanzapine is effective in maintaining the clinical improvement during continuing therapy in patients who have shown initial treatment response. Eli Lilly (M) Sdn. Bhd.
5. Rantudil Capsule 60mg [Acemetacin] Pain and restricted mobility associated with:

– chronic rheumarthritis (chronic polyarthritis, rheumatoid arthritis)

– chronic rheumarthritis with psoriatic arthritis

– state of acute irritation due to degenerative joint disease, particularly of the large joints and spinal coloum (activated arthrosis/spondylarthrosis)

– Bekhterev’s disease (rheumatoid spondylitis)

– Gout attacks

– Inflammation of joints, muscles or tendons, tenosynovitis, bursitis

– Lumbago-sciatica

– State of imflammation and swelling after operations and blunt injuries

– Inflammation of superficial veins (thrombophlebitis) and other vessels (vasculitis)

Bayer (M) Sdn. Bhd.
6. Omniscan 0.5mmol/ml, 5ml [Gadodiamide] Contrast medium for cranial and spinal magnetic resonance imaging (MRI) for intravenous administration. The product provides contrast enhancement structures or lesions in the CN Kyowa Hakko (M) Sdn. Bhd.
7. Omniscan 0.5mmol/ml, 10ml [Gadodiamide] Contrast medium for cranial and spinal magnetic resonance imaging (MRI) for intravenous administration. The product provides contrast enhancement structures or lesions in the CNS. Kyowa Hakko (M) Sdn. Bhd.
8. Omniscan 0.5mmol/ml, 15ml [Gadodiamide] Contrast medium for cranial and spinal magnetic resonance imaging (MRI) for intravenous administration. The product provides contrast enhancement structures or lesions in the CNS. Kyowa Hakko (M) Sdn. Bhd.
9. Omniscan 0.5mmol/ml, 20ml [Gadodiamide] Contrast medium for cranial and spinal magnetic resonance imaging (MRI) for intravenous administration. The product provides contrast enhancement structures or lesions in the CNS. Kyowa Hakko (M) Sdn. Bhd.