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868 items
Announcements, product safety communications and regulatory updates.
Overview Varenicline is used in smoking cessation treatment by relieving the craving and withdrawal symptoms associated with stopping smoking. It can also reduce the enjoyment of cigarettes if…
Overview Montelukast is used to prevent and treat chronic asthma in adults and children above 12 months of age. It is also indicated in adults and children above 2 years of age for the relief of…
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Overview Isoniazid is an antibiotic used in the treatment of tuberculosis. It can be used alone (prevention) or in combination with other antituberculosis drugs (treatment). Pancreatitis is an…
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Background: Saccharomyces boulardii is a live yeast used as a probiotic. Previously, Saccharomyces boulardii -containing products have been contraindicated in patients with central venous catheter…
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Overview: Azithromycin, clarithromycin, erythromycin and roxithromycin are antibiotics from the macrolides group which have broad-spectrum action on various bacteria including Gram-positive and…
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Overview: Apixaban (Eliquis®) is an oral anticoagulant indicated for prevention and treatment of venous thromboembolic events (VTE)1. Antidepressants belonging to the Selective Serotonin Reuptake…
PRESS STATEMENT DIRECTOR GENERAL OF HEALTH COSMETIC PRODUCTS FOUND TO CONTAIN SCHEDULED POISON 1. The National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia (MOH) would like to…
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NPRA is proud to announce the launch of our new website which coincides with our mission to safeguard the nation's health through scientific excellence in the regulatory control of medicinal products…
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KENYATAAN AKHBAR KETUA PENGARAH KESIHATAN MALAYSIA PRODUK-PRODUK KOSMETIK YANG DIKESAN MENGANDUNGI RACUN BERJADUAL 1. Bahagian Regulatori Farmasi Negara (NPRA), Kementerian Kesihatan Malaysia (KKM)…
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Overview Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that exhibits virological suppression, reducing the amount of virus in the body. Efavirenz is commonly used along with…
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Overview Propofol is a short-acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia. It may also be used for sedation. Sodium valproate is a broad-spectrum…
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Overview Pemetrexed is a chemotherapy agent approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) and mesothelioma. Currently there are six (6) products…
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Overview Methotrexate is a disease-modifying anti-rheumatic drug (DMARD) and also an anti-neoplastic agent. The current registered indications of methotrexate include oncologic indications such as…
Overview Mesalazine, or 5-aminosalicylic acid (5-ASA), is an anti-inflammatory agent used in the management of inflammatory bowel diseases, such as ulcerative colitis and Crohn’s disease. It helps in…
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Overview Direct-acting antivirals (DAAs) have been developed to treat hepatitis C virus (HCV) infection by targeting various steps in the HCV lifecycle. These drugs have been proven to produce higher…
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Overview Carbocisteine and acetylcysteine (also known as N-acetylcysteine or NAC) are cysteine derivatives indicated for use as mucolytic agents. They are assumed to reduce mucus viscosity by…
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Overview Amoxicillin is an antibiotic from the penicillin group and has broad-spectrum action on both Gram-positive and Gram-negative bacteria. Background of Safety Issue The European Medicines…
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Dimaklumkan bahawa terdapat individu tidak bertanggungjawab yang telah menggunakan nama NPRA untuk tujuan kutipan derma / sumbangan / tajaan NPRA tidak pernah memberi sokongan / bekerjasama dengan…
Overview: Stress cardiomyopathy, also referred to as Takotsubo cardiomyopathy, is an acute condition associated with transient left ventricular dysfunction1. There are several clinical manifestations…
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Overview: Domperidone has been known to be associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of…
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Description: The risk of developing abuse and dependence with zolpidem has been found to increase with a treatment duration above 28 days and in patients with previous or concomitant history of…
MADRAC Bulletin - Issue 01/2018 Features ▪ Recent Safety Issues with Fluoroquinolones Articles based on Case Reports ▪ Simvastatin: Reminder on the Risk of Cognitive Impairment ▪ Dipeptidyl…
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Direktif BPFK/PPP/01/03/J3(11) bertarikh 27 Jun 2014 adalah dirujuk. Garispanduan untuk prosedur kawalan regulatori API boleh didapati di Guidance Notes Required Documents for API Information Version…
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Overview Iodinated contrast media (ICM) is used in medical X-ray imaging to distinguish physiologically normal and abnormal features1. Different ICMs vary greatly in their physical and chemical…
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Sila ambil perhatian bahawa laporan kajian BE untuk tujuan pendaftaran semula HANYA perlu dikemukakan kepada pihak NPRA dalam tempoh enam (6) hingga dua belas (12) bulan sebelum tamatnya tempoh sah…
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