| Code | 6861E | ||||||||||
| MA number | 44/0178/24-S | ||||||||||
| Product Form: | cps dur 28x150 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: |
|
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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: | 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 |
