Eltrombopag Alpha-Medical 25 mg filmom obložene tablete
Name | Eltrombopag Alpha-Medical 25 mg filmom obložene tablete |
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Marketing Authorisation Number | HR-H-323312646 |
Active Substance | eltrombopagolamin |
Composition | jedna filmom obložena tableta sadrži 25 mg eltrombopaga u obliku eltrombopagolamina |
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 | 03.10.2023 |
MA Period of Validity | 03.10.2028 |
Classification Number | UP/I-530-09/21-01/309 |
Registration Number | 381-12-01/171-23-07 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | B02BX05 |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |