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Announcements, product safety communications and regulatory updates.
Dimaklumkan bahawa adalah wajib untuk melampirkan Screening Checklist untuk semua permohonan baharu untuk Ubat Generik (Prescription-Full) berkuat kuasa 1 Ogos 2023. Kegagalan berbuat demikian akan…
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Please be informed that it is mandatory to attach the Screening Checklist for all new applications for Generic Medicines (Prescription-Full) effective 1 Aug 2023. Failure to do so will result in…
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Sukacita dimaklumkan bahawa pada 19 Januari 2024, Bahagian Regulatori Farmasi Negara (NPRA) telah meluluskan permohonan variasi daripada syarikat Pharmaniaga Lifescience Sdn. Bhd., berhubung…
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Overview Anastrozole, exemestane, and letrozole are categorised as third-generation aromatase inhibitors approved for the treatment of hormone receptor-positive breast cancer in postmenopausal…
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 judgment. While reasonable…
KENYATAAN-MEDIA-KPK---KELULUSAN-PENDAFTARAN-PERTAMA-BAGI-PRODUK-SEMULAJADI-DENGAN-TUNTUTAN-TERAPEUTIK
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Sukacita dimaklumkan bahawa pada 2 Jun 2023, Bahagian Regulatori Farmasi Negara (NPRA) telah meluluskan permohonan variasi daripada syarikat ASTRAZENECA Sdn. Bhd., berhubung pengemaskinian tempoh…
KENYATAAN-MEDIA-KPK---PANGGILAN-BALIK-PRODUK-YANG-MENGANDUNGI-PHOLCODINE-BERIKUTAN-RISIKO-ANAPHYLAXIS-DENGAN-PENGGUNAAN-NEUROMUSCULAR-BLOCKING-AGENTS-NMBAs---23-MAC-2023
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Product Overview Terlipressin (Glypressin®) is a vasopressin analogue indicated for the treatment of type 1 hepatorenal syndrome (HRS), characterised by spontaneous acute renal insufficiency in…
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Overview Griseofulvin is a fungistatic antifungal agent indicated for the treatment of fungal infections caused by Epidermophyton, Microsporum, and Trichophyton species.1 It inhibits fungal cell…
Overview The Comirnaty vaccine is a messenger RNA (mRNA)-based vaccine indicated for active immunisation against COVID-19 infections caused by SARS-CoV-2.1-2 It contains nucleotide-modified mRNA that…
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Overview Azacitidine is a hypomethylating agent approved in Malaysia for the treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML).1…
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Sukacita dimaklumkan bahawa pada 4 April 2023, Bahagian Regulatori Farmasi Negara (NPRA) telah meluluskan permohonan variasi daripada syarikat Pfizer (Malaysia) Sdn. Bhd., berhubung pengemaskinian…
[INVITATION] SEMINAR: ISPE Malaysia Education Series: Strengthening GDP Fundamentals ISPE Malaysia is organizing 2023 ISPE Education Event as follows: Theme : ISPE Malaysia Education Series…
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Overview Diclofenac is a non-steroidal anti-inflammatory (NSAID) that exhibits pronounced anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties.1-3 Its therapeutic effects are…
An Analysis of Deficiencies Observed During On-Site Good Manufacturing Practice (GMP) Inspections of Local and Foreign Manufacturing Premise of Medicinal Registered Products in the Year 2022 1.0…
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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 maklum balas yang…
Dear Sir / Madam,Bahagian Regulatori Farmasi Negara (NPRA) is conducting a survey to assess the level of customer satisfaction with the services provided by NPRA. Through the feedback received, NPRA…
KENYATAAN-MEDIA-KPK---MAKLUMAN-PRODUK-KOSMETIK-YANG-DIKESAN-MENGANDUNGI-RACUN-BERJADUAL---22-MAC-2023.pdf
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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…
Semua permohonan baharu untuk Ubat Generik (Prescription-Full) perlu mengisytiharkan status pendaftaran produk di negara lain (worldwide registration status) menggunakan templat khusus ini [tarikh…
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