Sunitinib Alpha-Medical 50 mg tvrde kapsule
| Name | Sunitinib Alpha-Medical 50 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-177048932 |
| Active Substance | sunitinibmalat |
| Composition | Jedna kapsula sadrži 50 mg sunitiniba u obliku sunitinibmalata |
| Pharmaceutical Form | Kapsula, tvrda |
| Packaging [MA Number for Packaging] | 28 kapsula u blisteru, u kutiji [HR-H-177048932-01] 30 kapsula u blisteru, u kutiji [HR-H-177048932-02] 28 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-177048932-03] 30 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-177048932-04] 30 kapsula u bočici, u kutiji [HR-H-177048932-05] |
| Manufacturer | Synthon s.r.o., Blansko, Češka
Synthon BV, Nijmegen, Nizozemska Synthon Hispania S.L., Barcelona, Španjolska |
| Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date | 17.06.2021 |
| MA Period of Validity | 17.06.2026 |
| Classification Number | UP/I-530-09/19-01/281 |
| Registration Number | 381-12-01/154-21-02 |
| 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 |
