Medicinal Products

Glimepirid PharmaS 3 mg tablete

Name Glimepirid PharmaS 3 mg tablete
Marketing Authorisation Number HR-H-625922856
Active Substance glimepirid
Composition jedna tableta sadrži 3 mg glimepirida
Pharmaceutical Form tableta
Packaging [MA Number for Packaging] 30 tableta u blisteru, u kutiji  [HR-H-625922856-01]
60 tableta u blisteru, u kutiji  [HR-H-625922856-02]
Manufacturer PharmaS d.o.o., Zagreb, Republika Hrvatska
Marketing Authorisation Holder PharmaS d.o.o., Radnička cesta 47, Zagreb
Marketing Authorisation Date 18.08.2017
MA Period of Validity unlimited
MA Revocation Date 15.11.2022*
Classification Number UP/I-530-09/16-02/274
Registration Number 381-12-01/38-17-02
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code A10BB12
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.

Back