Code | 6367E | ||||||||||
MA number | EU/1/21/1603/004 | ||||||||||
Product Form: | tbl flm 120 (15x8)x240 mg (blis.PVC/Aclar/Al) | ||||||||||
MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Amgen Europe B.V., Netherland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 06.01.2022 |
Validity: | 07.01.2025 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 15.07.2024 |