| Name |
Sunitinib BE PHARMA 50 mg tvrde kapsule |
| Marketing Authorisation Number |
HR-H-612567104 |
| Active Substance |
sunitinibmalat |
| Composition |
jedna tvrda kapsula sadrži 50 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-530-09/21-01/214 |
| Registration Number |
381-12-01/70-23-04 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
L01EX01 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
