| Name |
Sorafenib Remedica 200 mg filmom obložene tablete |
| Former Name |
Sorafenib Alpha-Medical 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 |
Remedica Ltd., Aharnon Street, Limassol Industrial Estate, Limassol, Cipar |
| Marketing Authorisation Date |
09.04.2021 |
| MA Period of Validity |
28.10.2025 |
| Classification Number |
UP/I-530-09/19-01/187 |
| Registration Number |
381-12-01/154-21-20 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
L01XE05 |
| Medicinal product marketed in the Croatia |
Privremeni prekid opskrbe |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
