Code | 7535E | ||||||||||
MA number | 44/0225/24-S | ||||||||||
Product Form: | cps dur 112x1x200 mg (blis.OPA/Al/PVC//Al - jednotk.bal.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Viatris Limited, Ireland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 10.09.2024 |
Validity: | 10.09.2029 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Nilotinib Viatris 200 mg_09.2024.pdf |
PIL: | PIL_Nilotinib Viatris 200 mg_09.2024.pdf |
Safety feature | Yes |
Data update: | 16.09.2024 |