Nilotinib Zentiva 150 mg tvrde kapsule
| Name | Nilotinib Zentiva 150 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-293791760 |
| Active Substance | nilotinibklorid hidrat |
| Composition | jedna tvrda kapsula sadrži 150 mg nilotiniba (u obliku klorid dihidrata) |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | PharOS MT Ltd, Birzebbugia, Malta
Pharos Pharmaceutical Oriented Services Ltd., Metamorfossi Attikis, Grčka |
| Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date | 27.06.2024 |
| MA Period of Validity | 27.06.2029 |
| Classification Number | UP/I-530-09/23-01/97 |
| Registration Number | 381-12-01/70-24-10 |
| 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 | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
