Code | 6867E | ||||||||||
MA number | 44/0179/24-S | ||||||||||
Product Form: | cps dur 28x200 mg (blis.OPA/Al/PVC//Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Zentiva, k.s., Czechia | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
|
||||||||||
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: | 22.07.2024 |
Validity: | 22.07.2029 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Nilotinib Zentiva_07_2024.pdf |
SPC: | SPC_Nilotinib Zentiva_07_2024.pdf |
Safety feature | Yes |
Data update: | 13.08.2024 |