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Announcements, product safety communications and regulatory updates.
Makluman Tarikh Keputusan Pihak Berkuasa Kawalan Dadah (PBKD) Berkenaan Pengecualian Daripada Keperluan Menjalankan Ujian Fizikal Untuk Aktiviti Lot Release Bagi Semua Produk Vaksin COVID-19…
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Introduction According to World Health Organisation (WHO), vaccination will be an important tool to stop the COVID-19 pandemic. Now, a year after the pandemic erupted, more than 60 COVID-19 vaccine…
Direktif Tarikh Pekeliling Berkenaan Pelaksanaan Prosedur Kerja Penilaian Desktop Bagi Aktiviti Pemeriksaan Amalan Perkilangan Baik (APB) Ke Atas Premis Pengilang Farmaseutikal Luar Negara 11…
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Direktif Tarikh Direktif Berkenaan Pengukuhan Pelaksanaan Kawalan Regulatori Ke Atas Produk - Produk Gas Perubatan Dan Penggunaan Guideline On Registration Of Medicinal Gases Lampiran A : Guideline…
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Direktif Tarikh Direktif Untuk Penggunaan Drug Registration Guidance Document (DRGD) Third Edition, January 2021 29 Januari 2021
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Overview Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in the combination treatment of human immunodeficiency virus (HIV-1).1 Currently, there are 11 products…
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Overview Mesalazine and sulfasalazine are anti-inflammatory agents from the 5-aminosalicylic acid (5-ASA) group which are commonly used for the treatment of inflammatory bowel disease (IBD), such as…
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Overview In Malaysia, oseltamivir is generally indicated for treatment and post-exposure prophylaxis of influenza infection for adults and children.1 Oseltamivir is an antiviral drug that acts…
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Overview Clozapine is an atypical antipsychotic agent which is indicated in patients with treatment-resistant schizophrenia.1 It is also indicated to reduce the risk of recurrent suicidal behavior in…
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Overview Abiraterone is an androgen hormone antagonist that helps to reduce the level of testosterone and other androgen hormone in the blood.1 It is indicated with prednisone or prednisolone for…
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Overview Ondansetron is a 5-HT3 receptor antagonist indicated for the prevention of nausea and vomiting induced by chemotherapy and radiotherapy. It is also indicated for prevention and treatment of…
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Description Lemtrada® (alemtuzumab) is a disease modifying drug that is indicated in adults with highly active relapsing remitting multiple sclerosis (RRMS). New safety information has been…
Overview Tumour Necrosis Factor alpha (TNFα) inhibitors have been used in the treatment of chronic inflammatory diseases such as rheumatoid arthritis and Crohn’s disease.1 As TNFα is naturally…
The training program consists of 13 on-line courses. These courses cover the essential principles of Quality Assurance (QA) Good Manufacturing Practice (GMP). Participants are expected to gain an…
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To all our valued QUEST 3+ users, All online payment transactions which includes payment method using Credit Card (CC), Personal Account (B2C) and Corporate Account (B2B) via the QUEST3+ system will…
The National Pharmaceutical Regulatory Agency (NPRA) wishes to advise the public on the risks of kidney-related and liver-related adverse reactions related to ganoderma which is also known as lingzhi…
Description The National Pharmaceutical Regulatory Agency (NPRA) would like to inform healthcare professionals regarding the withdrawal of product registration of Esmya 5 mg tablet (ulipristal…
Makluman Tarikh Pekeliling Berkenaan Keperluan Pengujian Impuriti Nitrosamine Bagi Produk Yang Mengandungi Angiotensin II Receptor Blockers (ARB), Ranitidine dan Metformin 8 Disember 2020
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Document Name Updated Guidelines on Conditional Registration for New Chemical Entities and Biologics - 2nd Edition December 2020
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Description In Malaysia, fingolimod is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients and in paediatric patients of 10 years old and above to reduce the…
Overview Parenteral nutrition (PN) is indicated in paediatric and adult patients who cannot be fully fed or are fed enterally due to medical conditions such as severe intestinal failure…
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Overview Propofol is indicated for the induction and maintenance of general anesthesia or sedation in children and adults during surgical or other diagnostic procedures.1 Currently, there are 10…
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Description: In Malaysia, Plaquenil® is approved for the treatment of rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused…
