Medicinal Products

Emtricitabin/tenofovirdizoproksil Remedica 200 mg/245 mg filmom obložene tablete

Name Emtricitabin/tenofovirdizoproksil Remedica 200 mg/245 mg filmom obložene tablete
Former Name Emtricitabin/tenofovirdizoproksil Alpha-Medical 200 mg/245 mg filmom obložene tablete
Marketing Authorisation Number HR-H-279516622
Active Substance emtricitabin
tenofovirdizoproksilsukcinat
Composition jedna filmom obložena tableta sadrži 200 mg emtricitabina i 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilsukcinata)
Pharmaceutical Form filmom obložena tableta
Manufacturer Remedica Ltd., Limassol, Cipar
Marketing Authorisation Holder Remedica Ltd., Aharnon Street, Limassol Industrial Estate, Limassol, Cipar
Marketing Authorisation Date 03.03.2022
MA Period of Validity unlimited
MA Revocation Date 17.07.2025*
Classification Number UP/I-530-09/21-02/87
Registration Number 381-12-01/38-22-03
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 J05AR03
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Marketing authorisation has been revoked by request of the marketing authorisation holder.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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