Sorafenib Viatris 200 mg filmom obložene tablete
| Name | Sorafenib Viatris 200 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-665195647 |
| Active Substance | sorafenibtosilat |
| Composition | jedna filmom obložena tableta sadrži 200 mg sorafeniba (u obliku tosilata) |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Remedica Ltd., Limassol, Cipar PharOS MT Ltd, Birzebbugia, Malta |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 26.06.2024 |
| MA Period of Validity | 11.09.2025 |
| Classification Number | UP/I-530-09/19-01/270 |
| Registration Number | 381-12-01/286-24-28 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01EX02 |
| Marketing status | stavljeno u promet |
| Shortage status | u tijeku |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
