Medicinal Products

Oxygerolan 20 mg tablete s produljenim oslobađanjem

Name Oxygerolan 20 mg tablete s produljenim oslobađanjem
Marketing Authorisation Number HR-H-775337317
Active Substance oksikodonklorid
Composition jedna tableta s produljenim oslobađanjem sadrži 20 mg oksikodonklorida što odgovara 17,93 mg oksikodona
Pharmaceutical Form tableta s produljenim oslobađanjem
Packaging [MA Number for Packaging] 60 tableta u blisteru, u kutiji  [HR-H-775337317-01]
Manufacturer G.L. Pharma GmbH, Lannach, Austrija
Marketing Authorisation Holder Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb
Marketing Authorisation Date 26.04.2018
MA Period of Validity 26.04.2023
MA Revocation Date 12.10.2022*
Classification Number UP/I-530-09/16-01/270
Registration Number 381-12-01/70-18-08
Prescription na recept
Type of prescription poseban recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code N02AA05
Medicinal product marketed in the Croatia Da
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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.