Sorafenib Viatris 200 mg filmom obložene tablete
Name | Sorafenib Viatris 200 mg filmom obložene tablete |
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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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01EX02 |
Medicinal product marketed in the Croatia | Nestašica |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |