Eltrombopag Alpha-Medical 25 mg filmom obložene tablete
| Name | Eltrombopag Alpha-Medical 25 mg filmom obložene tablete |
|---|---|
| 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 | 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 | B02BX05 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
