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Announcements, product safety communications and regulatory updates.
Please note that for all payments made in QUEST 3+, due to manual back-end processing including verification of the online payments received, you may check the status of your payment(s) and status of…
Quest 3 + (E.13 Submission for Data Cleaning) For the purpose of data cleaning and E.13 update on approved product Applicant should submit the documents by separating the documents based on test…
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Date: 12 April 2018 Description: The Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA) started a review of Esmya®, to assess the link between Esmya® and cases of…
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Good Distribution Practice (GDP) 7 May 2018 (Monday) | 9.00 am – 5.00 pm Venue THE ROYALE CHULAN DAMANSARA, Petaling Jaya Who should attend Manufacturers, importers, wholesalers and relevant parties…
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National Regulatory Conference (NRC) 2018 Tuesday, 2 October 2018 until Thursday, 4 October 2018 Theme :Regulatory Excellence : The New Normal Venue : Hotel Royale Chulan Damansara, Selangor Contact…
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Pemeriksaan Apb Pengilang Veterinar & Keperluan Pemeriksaan Apb Pengilang Veterinar 24 & 25 April 2018 (Selasa & Rabu) Objectives 1. Memberi pendedahan kepada pengilang berkenaan direktif dan garis…
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Sejak kebelakangan ini, Bahagian Regulatori Farmasi Negara (NPRA) telah menerima laporan berkaitan kes penipuan atau scam menggunakan panggilan telefon. Didapati bahawa terdapat pelanggan NPRA yang…
New Safety Alerts Update : Levetiracetam and Methotrexate: Risk of Drug-drug Interaction Intravenous (IV) Fluids Containing Electrolytes and/or Carbohydrates: Risk of Hyponatraemia Gadolinium-based…
Background The National Pharmaceutical Regulatory Agency (NPRA) received information from the European Medicines Agency (EMA) on the risk of Jarisch-Herxheimer reaction (JHR) with doxycycline. The…
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Overview Gadolinium-based contrast agents (GBCA) are complexes of gadolinium (III) with different types of organic chelators. They are used for contrast enhancement in magnetic resonance imaging…
Overview Intravenous (IV) fluids are given to replenish substantial deficits or continuing losses from the body, or to maintain normal fluid and electrolyte requirements. The fluids used in clinical…
Overview Levetiracetam is one of the antiepileptic drugs used as adjunctive treatment or as monotherapy for epilepsy. Methotrexate is a chemotherapy agent and immune system suppressant used to treat…
MSC Trustgate USB token package with 3 years validity will be no longer offered. For more information, kindly contact MSC Trustgate Customer Care at 03-8318 1800. * Price stated in bracket inclusive…
Date : 13th March 2018 (Tuesday)Time: 8.30am - 12.30pmVenue: Hotel Royale Chulan The Curve Online Registration Form of Foreign GMP Regulatory Inspection 2019
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For a combination pack consists of registered products from different product owners/PRH, the application need to be submitted manually (please use the application form NPRA 500CP). 1. Applicant to…
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Date: 5 January 2018 Description: Cases of drug-induced liver injury (DILI) in patients treated with Ofev® have been reported worldwide in the post-marketing period, including a case of severe liver…
Date: 8 December 2017 Description: Preliminary data from a randomised clinical trial showed an increased incidence of fractures (24% vs. 7%) and deaths (27% vs. 20%) in patients with…
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Berita Ubat-ubatan, Volume 67, Mac 2017 DOWNLOAD PDF
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