Aksitinib Alpha-Medical 5 mg filmom obložene tablete
| Name | Aksitinib Alpha-Medical 5 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-636549762 |
| Active Substance | aksitinib |
| Composition | jedna filmom obložena tableta sadrži 5 mg aksitiniba |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Synthon Hispania S.L., Sant Boi de Llobregat, Španjolska
Synthon BV, Nijmegen, Nizozemska |
| Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date | 31.01.2023 |
| MA Period of Validity | 31.01.2028 |
| Classification Number | UP/I-530-09/21-01/237 |
| Registration Number | 381-12-01/70-23-06 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01EK01 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
