Nibufar 50 mg tvrde kapsule
Name | Nibufar 50 mg tvrde kapsule |
---|---|
Marketing Authorisation Number | HR-H-194495612 |
Active Substance | sunitinib |
Composition | jedna kapsula sadrži 50 mg sunitiniba |
Pharmaceutical Form | Kapsula, tvrda |
Manufacturer | Pharmacare Premium Ltd., Birzebbugia, Malta
Genepharm S.A., Pallini Attiki, Grčka |
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-530-09/20-01/171 |
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 |