Sunitinib Mylan 12,5 mg tvrde kapsule
Name | Sunitinib Mylan 12,5 mg tvrde kapsule |
---|---|
Marketing Authorisation Number | HR-H-868042036 |
Active Substance | sunitinib |
Composition | jedna kapsula sadrži 12,5 mg sunitiniba |
Pharmaceutical Form | kapsula, tvrda |
Manufacturer | Remedica Ltd., Limassol, Cipar Pharmacare Premium Ltd., Birzebbugia, Malta |
Marketing Authorisation Holder | Mylan Ireland Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Irska |
Marketing Authorisation Date | 26.03.2024 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/23-02/102 |
Registration Number | 381-12-01/171-24-07 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01EX01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |