Sorafenib Sandoz 200 mg filmom obložene tablete
| Name | Sorafenib Sandoz 200 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-511184111 |
| Active Substance | sorafenibtosilat |
| Composition | svaka filmom obložena tableta sadrži 200 mg sorafeniba (u obliku tosilata) |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Remedica Ltd., Limassol, Cipar
Lek Pharmaceuticals d.d., Ljubljana, Slovenija PharOS MT Ltd, Birzebbugia, Malta |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 10.09.2020 |
| MA Period of Validity | 10.09.2025 |
| Classification Number | UP/I-530-09/19-01/114 |
| Registration Number | 381-12-01/30-20-04 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01EX02 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
