Sorafenib Teva 200 mg filmom obložene tablete
Name | Sorafenib Teva 200 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-665169629 |
Active Substance | sorafenibtosilat |
Composition | svaka filmom obložena tableta sadrži 200 mg sorafeniba (u obliku tosilata) |
Pharmaceutical Form | filmom obložena tableta |
Manufacturer | Teva Operations Poland Sp. z o.o., Krakow, Poljska Merckle GmbH, Blaubeuren, Njemačka Teva Pharma B.V., Haarlem, Nizozemska Pliva Hrvatska d.o.o., Zagreb, Hrvatska Actavis Group PTC ehf., Hafnarfjoerdur, Island |
Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
Marketing Authorisation Date | 07.11.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/23-02/39 |
Registration Number | 381-12-01/171-23-04 |
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 |