Medicinal Products

Olanzapin PharmaS 5 mg raspadljive tablete za usta

Name Olanzapin PharmaS 5 mg raspadljive tablete za usta
Marketing Authorisation Number HR-H-152306858
Active Substance olanzapin
Composition jedna raspadljiva tableta za usta sadrži 5 mg olanzapina
Pharmaceutical Form raspadljiva tableta za usta
Packaging [MA Number for Packaging] 28 tableta u blisteru, u kutiji  [HR-H-152306858-01]
28 tableta u perforiranom blisteru, u kutiji  [HR-H-152306858-02]
Manufacturer PharmaS d.o.o., Zagreb, Hrvatska
Marketing Authorisation Holder PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska
Marketing Authorisation Date 16.12.2016
MA Period of Validity unlimited
MA Revocation Date 31.01.2024*
Classification Number UP/I-530-09/15-02/386
Registration Number 381-12-01/70-16-05
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code N05AH03
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Marketing authorisation has been revoked by request of the marketing authorisation holder.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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