Nibufar 25 mg tvrde kapsule
| Name | Nibufar 25 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-334983612 |
| Active Substance | sunitinib |
| Composition | jedna kapsula sadrži 25 mg sunitiniba |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | Genepharm S.A., Pallini Attiki, Grčka
Pharmacare Premium Ltd., Birzebbugia, Malta |
| Marketing Authorisation Holder | Farmex d.o.o., Ulica Ivane Brlić-Mažuranić 25, Varaždin, Hrvatska |
| Marketing Authorisation Date | 15.04.2022 |
| MA Period of Validity | 15.04.2027 |
| Classification Number | UP/I-530-09/20-01/170 |
| Registration Number | 381-12-01/154-22-10 |
| 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 |
