Sunitinib Mylan 37,5 mg tvrde kapsule
| Name | Sunitinib Mylan 37,5 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-063352486 |
| Active Substance | sunitinib |
| Composition | jedna kapsula sadrži 37,5 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-530-09/23-02/104 |
| Registration Number | 381-12-01/171-24-05 |
| 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 | L01EX01 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
