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Announcements, product safety communications and regulatory updates.
Background of Safety Issue The European Medicines Agency (EMA) has requested the product registration holders of fluoroquinolones (systemic and inhaled) to update the product information to include…
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Description Children exposed in utero to valproate are at risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases). Previously…
The 27th ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group (ACCSQ PPWG) will be held on 24-27 June 2019 at Hotel G Gurney, Penang, Malaysia. Save the date!…
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Salam sejahtera Tuan/Puan, Sukacita dimaklumkan bahawa sebahagian daripada usaha untuk menyelaraskan perkhidmatan kami kepada pihak industri, sebarang permohonan verifikasi terjemahan dokumen rasmi…
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Dear Sir / Madam, Please be informed that as part of our effort to streamline our services to the industry, any application for verification of translated official documents submitted to the Centre…
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MOPI Training - International Good Manufacturing Training Program 2018 The course training program consists of 9 technical modules and 7 additional trainings. These modules cover the essential…
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Document Name Download Updated Produk Valsartan Dan Losartan Yang Ditarik Balik Di Amerika Syarikat Serta Situasi Di Pasaran Malaysia DOWNLOAD 23 November 2018
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Download Press Release in PDF
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Asean GMP For Cosmetics 12 - 13 December 2018 (Wednesday & Thursday) Objectives 1. Introducing GMP training modules published by ASEAN for new cosmetic manufacturers. 2. Enhancing the understanding…
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Salam Sejahtera, Y.Bhg.Datuk/Dato'/Datin/Dr./Tuan/Puan, Dengan hormatnya perkara diatas dan Direktif Pelaksanan Pengawalan Bahan Aktif Farmaseutikal Bagi Produk Farmaseutikal Berdaftar Yang…
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Salam Sejahtera, Y.Bhg.Datuk/Dato'/Datin/Dr./Tuan/Puan, Adalah dimaklumkan Data Cleaning Modul akan ditutup sepenuhnya bermula 31 Disember 2018. Untuk permohonan bagi Approved Products Submit…
Pembayaran Atas Talian Sistem QUEST3+ 1. Apakah senarai bank yang boleh dipilih semasa melakukan pembayaran atas talian ? Senarai bank yang terlibat dengan pembayaran secara B2C ( tarikh kemaskini…
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1. How do I register new membership in Quest3+? *Company registration form (page with the scope of business related to pharmaceutical/health or cosmetic) must be attached together with the…
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Online Payment For QUEST3+ 1. What are the banks that participate in Quest3+ online payment ? List of participating banks for payment option B2C using personal account ( List updated : 13/11/2018)…
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Tahun 2022 DCA371 DCA370 DCA369 DCA368 Tahun 2021 DCA367 DCA366 DCA365 DCA363 DCA362 DCA361 DCA360 DCA359 DCA358 DCA357 DCA356 DCA355 DCA354 DCA353 DCA352 Tahun 2020 DCA351 DCA350 DCA349 DCA348…
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Description: New primary malignancies have been reported more frequently in patients treated with Xgeva® (denosumab 120mg once monthly) compared to zoledronic acid (4mg once monthly), according to…
Description: There is a potential safety issue related to cases of Neural Tube Defects (NTD) in infants born to women who were treated with antiretroviral regimens containing dolutegravir at the time…
Overview Succinylated gelatin (modified fluid gelatin) is a synthetic colloid used for volume replacement. It is iso-oncotic in relation to plasma and has a half-life of four (4) hours1. Background…
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Overview Eltrombopag is a small-molecule thrombopoietin receptor agonist indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) in splenectomised patients who are refractory…
Description: Healthcare professionals are informed of the new important identified risk of nephritis with use of Tecentriq® (atezolizumab). Atezolizumab is indicated for the treatment of patients…
Description: Healthcare professionals are informed of the new contraindication, restricted indication and liver function monitoring requirement for Esmya 5mg Tablets® (ulipristal acetate). Esmya® is…
Asean GMP For Cosmetics 12 - 13 December 2018 (Wednesday & Thursday) Objectives 1. Introducing GMP training modules published by ASEAN for new cosmetic manufacturers. 2. Enhancing the understanding…
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