Sorafenib Sandoz 400 mg filmom obložene tablete
Name | Sorafenib Sandoz 400 mg filmom obložene tablete |
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Marketing Authorisation Number | HR-H-143127575 |
Active Substance | sorafenibtosilat |
Composition | Jedna filmom obložena tableta sadrži 400 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 | 12.05.2021 |
MA Period of Validity | 12.05.2026 |
Classification Number | UP/I-530-09/20-01/83 |
Registration Number | 381-12-01/30-21-04 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01XE05 |
SmPC | download |
PL | download |
Public Assessment Report | download |