Nilotinib PGF Pharma 200 mg tvrde kapsule
| Name | Nilotinib PGF Pharma 200 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-127055638 |
| Active Substance | nilotinibdiklorid dihidrat |
| Composition | jedna tvrda kapsula sadrži 200 mg nilotiniba (u obliku nilotinibdiklorid dihidrata) |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | Devatis GmbH, Loerrach Baden-Wuerttemberg, Njemačka
PGF Pharma International d.o.o., Zagreb, Hrvatska |
| Marketing Authorisation Holder | PGF Pharma International d.o.o., Ulica Roberta Frangeša Mihanovića 9, Zagreb, Hrvatska |
| Marketing Authorisation Date | 16.06.2026 |
| MA Period of Validity | 16.06.2031 |
| Classification Number | UP/I-530-09/24-01/400 |
| Registration Number | 381-12-01/70-26-08 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01EA03 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
