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 |