| Name |
Sorafenib Alpha-Medical 200 mg filmom obložene tablete |
| Former Name |
Sorafenib Remedica 200 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-710862283 |
| Active Substance |
sorafenibtosilat |
| Composition |
jedna filmom obložena tableta sadrži 200 mg sorafeniba (u obliku sorafenibtosilata) |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
Remedica Ltd., Limassol, Cipar |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
29.10.2025 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/25-02/10 |
| Registration Number |
381-12-01/70-25-03 |
| 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 |
L01EX02 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
