Name |
Sunitinib BE PHARMA 37,5 mg tvrde kapsule |
Marketing Authorisation Number |
HR-H-483855710 |
Active Substance |
sunitinibmalat |
Composition |
jedna tvrda kapsula sadrži 37,5 mg sunitiniba u obliku sunitinibmalata |
Pharmaceutical Form |
Kapsula, tvrda |
Manufacturer |
Tecnimede - Sociedade Tecnico-Medicinal, S.A., Dois Portos, Portugal |
Marketing Authorisation Holder |
Be Pharma d.o.o., Brdnikova ulica 44, Ljubljana, Slovenija |
Marketing Authorisation Date |
10.02.2023 |
MA Period of Validity |
10.02.2028 |
Classification Number |
UP/I-530-09/21-01/213 |
Registration Number |
381-12-01/70-23-04 |
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 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|