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Announcements, product safety communications and regulatory updates.
Overview Tenofovir alafenamide (TAF) is a prodrug of the active metabolite tenofovir, which belongs to the drug group of nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). In Malaysia…
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Click Here for more information.
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Approved Additional Indication DCA 369 Approved Additional Indication DCA 368 Approved Additional Indication DCA 367 Approved Additional Indication DCA 366 Approved Additional Indication DCA 365…
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Rejection letter of BE studies conducted at the BE centre Micro Therapeutic Labs can be downloaded via the link below (both original and translated version):- Click Here To Download Thank you.
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Tuan / Puan,Bahagian Regulatori Farmasi Negara (NPRA) sedang menjalankan kajian untuk menilai tahap kepuasan pelanggan terhadap perkhidmatan yang diberikan oleh NPRA. Melalui maklumbalas yang…
Dear Sir / Madam,Bahagian Regulatori Farmasi Negara (NPRA) is conducting a survey to assess the level of customer satisfaction on the services provided by NPRA. Through the feedback received, NPRA…
Direktif Tarikh Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Second Revision January 2022 25 Januari 2022
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The training program consists of 14 on-line courses. These courses cover the essential principles of Quality Assurance (QA) and Good Manufacturing Practice (GMP). Participants are expected to gain an…
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Overview Rheumatoid arthritis (RA) is a chronic inflammatory disease in which the overactive immune system attacks the healthy joint tissues, causing pain, swelling, stiffness, and result in loss of…
Overview Rheumatoid arthritis (RA) is a chronic inflammatory disease in which the overactive immune system attacks the healthy joint tissues, causing pain, swelling, stiffness, and result in loss of…
The NPRA has updated information about this safety issue. See the NPRA Safety Alerts published on 7 August 2023. Overview Clindamycin is a lincosamide antibiotic indicated for the treatment of…
Overview Co-trimoxazole is an antibacterial product with a combination of sulfamethoxazole and trimethoprim.1 There are currently 16 products registered with the Drug Control Authority (DCA), with…
Dear Applicant, Recently we have received numerous complaints regarding problem on accessing QUEST3+ System. User who use Avast as antivirus have problem accessing QUEST system as Avast blocked…
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Direktif Tarikh Direktif untuk menerima permohonan Kebenaran Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) bagi produk vaksin COVID-19 keluaran pengilang tempatan yang…
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Overview Decitabine is a hypomethylating agent1 that selectively inhibits DNA methylation and is indicated for the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML) in…
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Rejection letter of BE studies conducted at the BE centres Synchron Research Services and Panexcell Clinical Lab can be downloaded via the links below: 1) Translated version: Rejection of…
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Surat penolakan kajian BE yang dijalankan oleh pusat kajian BE Synchron Research Services dan Panexcell Clinical Lab boleh dimuat turun melalui pautan dibawah:- 1) Penolakan Kajian Bioekuivalens (BE)…
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Overview Anastrozole is a potent and highly selective non-steroidal aromatase inhibitor, which is indicated for the treatment of breast cancer in postmenopausal women.1 Depression is a mental…
