Sunitinib Krka 12,5 mg tvrde kapsule
| Name | Sunitinib Krka 12,5 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-808339639 |
| Active Substance | sunitinibmalat |
| Composition | jedna tvrda kapsula sadrži sunitinibmalat, što odgovara 12,5 mg sunitiniba |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | Krka d.d., Novo mesto, Novo Mesto, Slovenija Synthon s.r.o., Blansko, Češka Synthon Hispania S.L., Barcelona, Španjolska Synthon BV, Nijmegen, Nizozemska Krka - farma d.o.o., Zagreb, Hrvatska |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 18.05.2021 |
| MA Period of Validity | 18.05.2026 |
| Classification Number | UP/I-530-09/20-01/50 |
| Registration Number | 381-12-01/154-21-04 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01EX01 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
