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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01EK01 |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |