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Announcements, product safety communications and regulatory updates.
With respect to the above matter, Following the implementation of Regulatory control of API for registered products* with registration expiration starting 1 January 2020, product registration holders…
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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, this page is available for…
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Kenyataan akhbar ini dikeluarkan berikutan notis panggil balik oleh Health Sciences Authority (HSA), Singapura ke atas tiga (3) produk yang mengandungi losartan daripada sumber bahan aktif Hetero…
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Bahagian Regulatori Farmasi Negara (NPRA), Kementerian Kesihatan Malaysia telah mengeluarkan arahan panggil balik ke atas produk berdaftar Kin Foong San (Medicinal Powder) 4gm (MAL19972851T)…
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Background of Safety Issue (i) Risk of birth defects and neonatal disorders in case of exposure during pregnancy In December 2018, based on the assessment of epidemiological studies and case reports…
Overview: Oral retinoids are vitamin A derivatives which are used to treat severe acne, severe forms of psoriasis, and other skin conditions1. There are three (3) types of oral retinoids registered…
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Overview Tapentadol is an opioid analgesic indicated for the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. Background NPRA has received information from the…
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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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We are pleased to announce the implementation of online APPEAL application procedure via QUEST3+ system starting 1st May 2019. This new procedure is applicable for product registration application…
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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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QUEST3+ System use myGovXchange as online payment service for B2C (Perconal / Current Account) and B2B (Corporate Account). myGovXchange is One Stop Center for Government's Online Payment and…
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Bahagian Regulatori Farmasi Negara (NPRA), Kementerian Kesihatan Malaysia (KKM) ingin menggesa orang awam untuk mengelak daripada membeli dan menggunakan produk tradisional berikut yang telah dikesan…
Overview Xylometazoline is used for the symptomatic relief of nasal congestion in colds and to aid drainage of secretions in sinus conditions. It is also indicated as an adjuvant to decongest the…
Overview Direct-Acting Antivirals (DAAVs) act by targeting specific non-structural proteins of the hepatitis C virus (HCV) which results in disruption of viral replication and infection. DAAVs…
Dear QUEST Users, Please be reminded that all pending payment need to be settled within 30 days calendar. The status will be 'expired pending payment 'once it over 30 days calendar and you will not…
Kepada Pengguna QUEST, Mohon peringatan untuk semua status ' Pembayaran yang belum diselesaikan' atau 'Pending Payment', Pembayaran hendakalah dibuat dalam tempoh 30 hari kalendar. Status akan…
KENYATAAN AKHBAR KEMENTERIAN KESIHATAN MALAYSIA PENJUALAN PRODUK HERBA UNTUK MEMULIH & MENCEGAH DEMAM DENGGI Kementerian Kesihatan Malaysia (KKM) telah menerima aduan mengenai produk herba yang…
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Background of Safety Issue The United States Food and Drug Administration (US FDA) warned that lamotrigine can cause a very rare but serious reaction called Hemophagocytic Lymphohistiocytosis (HLH)…
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Overview: Ceftriaxone is a widely used third-generation cephalosporin with a broad antimicrobial spectrum. Background: The National Pharmaceutical Regulatory Agency (NPRA) received information from…
Overview Beta-lactam antibiotics are among the most commonly prescribed drugs, grouped together based upon a shared structural feature, the beta-lactam ring. Beta-lactam antibiotics include the…
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Overview Acetazolamide is a carbonic anhydrous inhibitor. By acting on renal tubules, it increases excretion of bicarbonate, sodium and potassium resulting in alkaline diuresis1. It is commonly used…
