Official Malaysian Government Website
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Announcements, product safety communications and regulatory updates.
We have received numerous enquiry and complaints regarding Java security like below: For temporary solution, we have provide this guidelines for application who is having this problem : 1. From your…
#MedSafetyWeek starts today 💊 (Read the media statement here) You can help us make medicines safer for everyone. Please report any suspected side effects from medicines to the NPRA (👉 as a healthcare…
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Join us next week for #MedSafetyWeek! 82 countries are getting together to encourage reporting of suspected side effects from medicines. Get involved and help us make medicines safer for all. Please…
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Overview Methadone is a synthetic opioid that has similar properties to morphine.1 In Malaysia, the Drug Control Authority (DCA) had approved six (6) products containing methadone in syrup form for…
Kepada semua pengguna QUEST 3+ yang dihormati, Semua proses pembayaran dalam talian termasuk cara pembayaran menggunakan Kad Kredit (CC), Akaun Persendirian (B2C) dan Akaun Korporat (B2B) melalui…
Overview Piperacillin belongs to the ß-lactam antibiotics which are active against a range of gram-positive and gram-negative aerobic and anaerobic bacteria. However, it has less activity against…
Overview Iodinated contrast media (ICM) are medical imaging dyes used to enhance the ability for viewing the insides of various body parts such as blood vessels, tissues, and organs. ICM are…
Sukacita dimaklumkan bahawa pada 11 Oktober 2022, Bahagian Regulatori Farmasi Negara (NPRA) telah meluluskan permohonan variasi daripada syarikat Pfizer (Malaysia) Sdn. Bhd., berhubung pengemaskinian…
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Overview In Malaysia, there are currently eight (8) types of COVID-19 vaccines conditionally registered with the Drug Control Authority (DCA), namely Comirnaty, Vaxzevria, CoronaVac, Spikevax…
Overview Labetalol is a combined alpha and beta-adrenoreceptor antagonist indicated for the treatment of hypertension, including hypertension in pregnancy, as well as angina pectoris with co-existing…
Overview Sertraline is an antidepressant that belongs to the group of Selective Serotonin Reuptake Inhibitors (SSRIs). In Malaysia, the Drug Control Authority has currently approved 12…
Overview Nirmatrelvir/ritonavir is a new drug combination developed for the treatment of COVID-19 infection. In Malaysia, nirmatrelvir/ritonavir is indicated for the treatment of COVID-19 in adults…
Product Overview Brolucizumab (Pagenax®) is a humanised monoclonal antibody indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults. At present, there is one…
Product Overview Alectinib (Alecensa®) as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer…
Publication of revised PIC/S Annex 1 On 19 September 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published the revised Annex 1 to the PIC/S GMP Guide on the manufacture of…
DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While…
Press-Release-Sept-22
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Surat PBKD Tarikh Penarikan Balik Syarat Pendaftaran Khas Bagi Vaksin COVID-19: Hanya Boleh Dijual Atau Dibekal Kepada Pihak Kerajaan Atau Pihak Yang Diberi Kebenaran Oleh Kerajaan Sahaja Rujukan…
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Press-release-Aug-2022
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Pekeliling Tarikh Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2021 5 Ogos 2022
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1.1 MAKLUMAN PENGEMASKINIAN TEMPOH JANGKA HAYAT VAKSIN COMIRNATY (ADULT & PEDIATRIC DOSE) DARIPADA 9 BULAN KEPADA 12 BULAN 1.2 MAKLUMAN PENGEMASKINIAN TEMPOH JANGKA HAYAT VAKSIN CORONAVAC (FIRST &…
OBJEKTIF 1. Mengiktiraf dan menghargai kakitangan Bahagian Regulatori Farmasi Negara (NPRA) yang telah mencapai tahap kecemerlangan; 2. Menggalakkan persaingan sihat di kalangan warga kerja NPRA…
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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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This information is an update to the NPRA Safety Alerts: Betamethasone (Systemic): Risk of Pheochromocytoma Crisis published on 6 April 2022. Overview Corticosteroids are anti-inflammatory drugs…
