Medicinal Products

Zesuva 12,5 mg tvrde kapsule

Name Zesuva 12,5 mg tvrde kapsule
Former Name Sunitinib Alvogen 12,5 mg tvrde kapsule
Marketing Authorisation Number HR-H-931286789
Active Substance sunitinib
Composition jedna kapsula sadrži 12,5 mg sunitiniba
Pharmaceutical Form kapsula, tvrda
Manufacturer Remedica Ltd., Limassol, Cipar
Pharmacare Premium Ltd., Birzebbugia, Malta
Marketing Authorisation Holder Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka
Marketing Authorisation Date 15.06.2023
MA Period of Validity unlimited
MA Revocation Date 12.04.2024*
Classification Number UP/I-530-09/23-02/55
Registration Number 381-12-01/70-23-04
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

*Note

Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.

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