Medicinal Products

Dasatinib Pharmascience 20 mg filmom obložene tablete

Name Dasatinib Pharmascience 20 mg filmom obložene tablete
Marketing Authorisation Number HR-H-450592054
Active Substance dasatinib
Composition jedna filmom obložena tableta sadrži 20 mg dasatiniba (bezvodni oblik)
Pharmaceutical Form filmom obložena tableta
Manufacturer Pharmascience International Limited, Nicosia, Cipar
Marketing Authorisation Holder Pharmascience International Limited, Lampousas, 1, Nicosia, Cipar
Marketing Authorisation Date 13.05.2020
MA Period of Validity 13.05.2025
MA Revocation Date 13.09.2024*
Classification Number UP/I-530-09/19-01/34
Registration Number 381-12-01/154-20-04
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 L01EA02
Marketing status nije stavljeno u promet
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Marketing authorisation has been revoked by request of the marketing authorisation holder.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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