Sunitinib Alkaloid-INT 50 mg tvrde kapsule
Name | Sunitinib Alkaloid-INT 50 mg tvrde kapsule |
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Marketing Authorisation Number | HR-H-253142168 |
Active Substance | sunitinibmalat |
Composition | jedna kapsula sadrži sunitinibmalat, što odgovara 50 mg sunitiniba |
Pharmaceutical Form | Kapsula, tvrda |
Manufacturer | Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija |
Marketing Authorisation Holder | Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, Slovenija |
Marketing Authorisation Date | 13.01.2022 |
MA Period of Validity | 13.01.2027 |
Classification Number | UP/I-530-09/20-01/270 |
Registration Number | 381-12-01/38-22-03 |
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 |