Medicinal Products

Trandolapril PharmaS 4 mg kapsule

Name Trandolapril PharmaS 4 mg kapsule
Marketing Authorisation Number HR-H-360234336
Active Substance trandolapril
Composition jedna kapsula sadrži 4 mg trandolaprila
Pharmaceutical Form kapsula, tvrda
Packaging [MA Number for Packaging] 28 kapsula u blisteru, u kutiji  [HR-H-360234336-01]
56 kapsula u blisteru, u kutiji  [HR-H-360234336-02]
Manufacturer PharmaS d.o.o., Zagreb, Hrvatska
Marketing Authorisation Holder PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska
Marketing Authorisation Date 23.12.2015
MA Period of Validity unlimited
MA Revocation Date 30.08.2021*
Classification Number UP/I-530-09/14-02/525
Registration Number 381-12-01/30-15-03
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code C09AA10
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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.

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