Biosimilar Approved
- Posted By Seksyen Biologik
- Hits: 84859
User Rating: 5 / 5
| Date | |
| Biosimilars Approved |
8 Oct 2026 |
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Direktif untuk semua produk yang mengandungi Atorvastatin: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko reaksi fotosensitiviti (photosensitivity reaction)
- Posted By Seksyen Koordinasi Regulatori Produk & Kosmetik
- Hits: 2271
| Direktif | Tarikh |
| 19 Oktober 2026 |
Approved Clinical Trial Import License (CTIL) & Clinical Trial Exemption (CTX) Application
- Posted By Seksyen Penilaian & Keselamatan Produk Kajian
- Hits: 68592
User Rating: 4 / 5
| Document Name | |
| Status Kelulusan Permohonan CTIL/CTX Bulan April- Disember 2020 | 2020 |
| Status Kelulusan Permohonan CTIL/CTX Tahun 2021 | 2021 |
| Status Kelulusan Permohonan CTIL/CTX Tahun 2022 | 2022 |
| Status Kelulusan Permohonan CTIL/CTX Tahun 2023 | 2023 |
| Status Kelulusan Permohonan CTIL/CTX Tahun 2024 | 2024 |
| Status Kelulusan Permohonan CTIL/CTX Tahun 2025 | 2025 |
| Status Kelulusan Permohonan CTIL/CTX Tahun 2026 (Jan - Sept) | Jan - Sept 2026 |
National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
- Phone: +603-7883 5400
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- Last Modified: Tuesday 03 November 2026, 10:00:01.