Medicinal Products

Vorikonazol Pliva 50 mg filmom obložene tablete

Name Vorikonazol Pliva 50 mg filmom obložene tablete
Marketing Authorisation Number HR-H-118392315
Active Substance vorikonazol
Composition jedna tableta sadrži 50 mg vorikonazola
Pharmaceutical Form filmom obložena tableta
Packaging [MA Number for Packaging] 20 tableta u blisteru, u kutiji  [HR-H-118392315-01]
Manufacturer Pliva Hrvatska d.o.o., Zagreb, Republika Hrvatska
Marketing Authorisation Holder Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb
Marketing Authorisation Date 10.04.2019
MA Period of Validity unlimited
MA Revocation Date 03.12.2021*
Classification Number UP/I-530-09/17-02/580
Registration Number 381-12-01/70-19-05
Prescription na recept
Type of prescription neponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code J02AC03
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Educational materials
for healthcare professionals
Brošura s pitanjima i odgovorima za zdravstvene radnike, ver 2
Popis za provjeru za zdravstvene djelatnike, ver 2
Educational materials
for patients / caregivers
Kartica za bolesnika, ver 2

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Marketing authorisation has been revoked by request of the marketing authorisation holder.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