Medicinal Products

Tiaquin 200 mg filmom obložene tablete

Name Tiaquin 200 mg filmom obložene tablete
Former Name Kvetiapin Genera 200 mg filmom obložene tablete
Marketing Authorisation Number HR-H-436266496
Active Substance quetiapinum
Pharmaceutical Form filmom obložena tableta
Strength 200 mg
Packaging [MA Number for Packaging] 60 tableta u blisteru, u kutiji  [HR-H-436266496-01]
Manufacturer Genera d.d., Rakov Potok, Republika Hrvatska
Marketing Authorisation Holder Mylan Hrvatska d.o.o., Koranska 2, Zagreb
Marketing Authorisation Date 03.11.2017
MA Period of Validity unlimited
MA Revocation Date 04.03.2020*
Classification Number UP/I-530-09/16-02/479
Registration Number 381-12-01/70-17-07
Composition svaka tableta sadrži 200 mg kvetiapina u obliku kvetiapinfumarata
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code N05AH04
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Educational materials
for healthcare professionals
Podsjetnik o važnosti nadziranja metaboličkih parametara tijekom liječenja kvetiapinom, verzija 2


Marketing authorisation has been revoked by request of the marketing authorisation holder.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.