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Announcements, product safety communications and regulatory updates.
Overview Smecta® (dioctahedral smectite) is an edible natural clay used for the symptomatic treatment of diarrhoea. Background of Safety Issue NPRA has received information from the French National…
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This is to inform that there has been an update on the Guidance Notes for Active Pharmaceutical Ingredient (API) information required for product registration. The summary of changes is outlined…
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Kenyataan-Akhbar-KPK-30-Sept-19
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ONLINE REGISTRATION FOR ASEAN ACCSQ TMHS PWG 2019 We are pleased to inform you that the registration for The 32nd ASEAN Consultative Committee For Standards and Quality (ACCSQ) Traditional Medicines…
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Dengan hormatnya perkara diatas dan Direktif BPFK/PPP/01/03/J3(11) dirujuk. Kawalan regulatori Bahan Aktif Farmaseutikal (API) ke atas produk berdaftar* yang tamat tempoh pendaftaran mulai 1 Januari…
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Overview: Clopidogrel is an antiplatelet drug indicated for the secondary prevention of atherothrombotic events and the prevention of atherothrombotic/thromboembolic events in atrial fibrillation…
Description: LEMTRADA® (alemtuzumab) is indicated for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging…
With respect to the above and Directive BPFK/PPP/01/03/J3(11) is referred. Regulatory control of API for registered products* with registration expiration starting 1 January 2020 has been enforced…
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Overview Diclofenac is a non-steroidal compound with pronounced antirheumatic, anti-inflammatory, analgesic and antipyretic properties1. Background of Safety Issue The National Pharmaceutical…
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Description: Actemra® (tocilizumab) is a biological product indicated for rheumatoid arthritis in adults, polyarticular systemic juvenile idiopathic arthritis (pJIA) and systemic juvenile idiopathic…
Starting from 5 August 2019, all renewal applications for Manufacturer's / Importer's / Wholesaler's Licence for year 2020 can be made via Quest3+ system. Thank you.
Permohonan pembaharuan Lesen Pengilang / Mengimport / Pemborong untuk Tahun 2020 boleh dikemukakan melalui sistem Quest 3+ bermula 5 Ogos 2019. Sekian, terima kasih.
Bahagian Regulatori Farmasi Negara (NPRA), Kementerian Kesihatan Malaysia (KKM) ingin menggesa orang awam untuk mengelak daripada membeli dan menggunakan produk-produk kosmetik berikut kerana dikesan…
The Training Seminar on ICH Stability Guidelines (ICH-Q1) will be organised on 6th - 8th August 2019 by PhAMA in collaboration with NEU (Northeastern University, USA) and supported by NPRA, at the…
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Description: Zopiclone is a hypnotic agent, indicated for the treatment of insomnia. It is recommended to be used for the shortest duration possible, and not exceeding 4 weeks. The risk of developing…
Description TECENTRIQ® (atezolizumab) has been associated with the risk of immune-related myositis. In a comprehensive analysis that was performed across the TECENTRIQ® programme, cases of…
Overview Posaconazole is a triazole antifungal drug that exhibits broad-spectrum activity against yeasts and moulds, including those not generally responsive to azoles or which are resistant to other…
Overview Deferiprone is an iron-chelator that removes excess iron from the body in patients with thalassemia major when treatment with other iron chelators is inadequate or contraindicated…
Description DARZALEXTM (daratumumab) is indicated for the treatment of patients with multiple myeloma, and may be used in combination with other chemotherapy drugs, or as monotherapy in patients who…
Description An increased risk of serious psychiatric events such as depression, suicidal ideation or behavior, including suicides, or self-injury, has been observed in patients with systemic lupus…
Flyer-ISPE_V2_CGTP-14-AuFlyer-ISPE_V2_CGTP-14-Aug-2019.pdfg-2019
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Download MADRAC Bulletin 01/2019 Edition
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Bahagian Regulatori Farmasi Negara (NPRA), Kementerian Kesihatan Malaysia (KKM) ingin menggesa orang awam untuk mengelak daripada membeli dan menggunakan produk-produk kosmetik berikut kerana dikesan…
