| Code | 7318E | ||||||||||
| MA number | 44/0223/24-S | ||||||||||
| Product Form: | cps dur 40x1x200 mg (blis.PVC/PE/PVDC/Al) - jednotk.bal. | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| 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: | 27.08.2024 |
| Validity: | 27.08.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Nilotinib STADA 200 mg tvrdé kapsuly_09.2024.pdf
|
| PIL: |
PIL_Nilotinib STADA 200 mg tvrdé kapsuly_09.2024.pdf
|
| Safety feature | Yes |
| Data update: | 05.09.2024 |
