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Announcements, product safety communications and regulatory updates.
Overview Topiramate is indicated for the treatment of epilepsy, and also as prophylaxis against migraine headaches.1 (please see package insert for full prescribing details). Topiramate exerts the…
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Overview Cutaneous amyloidosis is a clump of abnormal amyloid proteins buildup in wave-like projections (dermal papillae) between the dermis and the epidermis.1 It may be associated with the use of…
Online public engagement is in line with the government's aspiration to support the principles of transparency and equality for the implementation of a law. Therefore, the Unified Public Consultation…
Sukacita dimaklumkan bahawa Seksyen AEB, Pusat Komplians dan Kawalan Kualiti (PKKK) akan menganjurkan satu sesi e-Engagement untuk memaklumkan kepada pihak industri yang terlibat berkenaan pelan…
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We are pleased to announce that the GDP Section, Centre of Compliance & Quality Control will be organizing an e-Engagement session in September 2020 with the industry to announce the phases of…
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Direktif Tarikh Pekeliling Berkenaan Pengemaskinian MiV-N Do & Tell Untuk Produk Farmaseutikal, Suplemen Kesihatan Dan Produk Semulajadi. 10 Julai 2020
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Overview Metoclopramide is generally indicated for the prevention of nausea and vomiting associated with chemotherapy or radiotherapy and symptomatic treatment of nausea and vomiting in adults. In…
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Diterbit pada: 24 Jun 2020 Kemaskini Terkini pada: 4 Oktober 2021 Assalamualaikum & Salam Sejahtera, YBhg. Datuk / Dato' / Datin / YBrs. Dr./ Tuan / Puan, Dengan hormatnya saya merujuk kepada perkara…
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Please be informed that there has been an update on the Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration. The updated document is available for…
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The training program consists of 10 on-line courses. These courses cover the essential principles of Good Manufacturing Practice (GMP). Participants are expected to gain an understanding of current…
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Overview Domperidone is a dopamine antagonist indicated for the relief of the symptoms of nausea and vomiting. It is thought to exert its antiemetic effect through antagonism of dopamine receptors in…
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Overview Proton pump inhibitors (PPI) are widely used for treatment of gastro-oesophageal reflux (GERD), Helicobacter pylori eradication, prophylaxis of gastrointestinal ulcer, as well as in patients…
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Overview Gabapentin is indicated for the treatment of epilepsy and neuropathic pain. In pre-clinical studies, gabapentin readily enters the brain and prevents seizures, while the analgesic activities…
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Overview Rocuronium is a non-depolarizing neuromuscular blocker.1 It is indicated as an adjunct to general anesthesia to facilitate endotracheal intubation, provide skeletal muscle relaxation as well…
Overview Nintedanib is a small molecule tyrosine kinase inhibitor (TKI) indicated for the treatment of idiopathic pulmonary fibrosis in adults. Nintedanib targets three key receptors including the…
PS-Apr-2020.pdf
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Overview Guselkumab (Tremfya®) is an anti-interleukin-23 monoclonal antibody indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic…
Overview The National Pharmaceutical Regulatory Agency (NPRA) would like to inform healthcare professionals regarding the voluntary recall initiated for Esmya 5 mg tablet (ulipristal acetate)…
Overview Intravenous iron-containing products are indicated for treatment of iron deficiency. Background The National Pharmaceutical Regulatory Agency (NPRA) received information from the European…
Overview Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb) indicated for the treatment of advanced melanoma as monotherapy in adults, or treatment of locally advanced or…
Description: Kyprolis® (carfilzomib) is indicated in combination with dexamethasone or lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who…
Description Esbriet® (pirfenidone) is an anti-fibrotic and anti-inflammatory agent indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Elevations of liver enzymes are a known risk of…
MADRAC Bulletin - 03/2019 Edition Articles based on Case Report ▪ Erythropoiesis-stimulating agents: A reminder on the cardiovascular risk in patients with chronic kidney disease ▪ Amiodarone: Risk…
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