| Name |
Sunitinib Alkaloid-INT 12,5 mg tvrde kapsule |
| Marketing Authorisation Number |
HR-H-372899304 |
| Active Substance |
sunitinibmalat |
| Composition |
jedna kapsula sadrži sunitinibmalat, što odgovara 12,5 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-530-09/20-01/268 |
| Registration Number |
381-12-01/38-22-05 |
| 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 |
| Marketing status |
trajni prekid opskrbe |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
