Medicinal Products

Abstral 400 mikrograma sublingvalne tablete

Name Abstral 400 mikrograma sublingvalne tablete
Marketing Authorisation Number HR-H-284002255
Active Substance fentanylum
Pharmaceutical Form sublingvalna tableta
Strength 400 mikrograma
Packaging [MA Number for Packaging] 10 tableta u blisteru, u kutiji  [HR-H-284002255-01]
Manufacturer Recipharm Stockholm AB, Jordbro, Švedska;
Aesica Queenborough Limited, Queenborough, Kent, Ujedinjeno Kraljevstvo
Marketing Authorisation Holder PharmaSwiss d.o.o., Strojarska 20, Zagreb
Marketing Authorisation Date 28.04.2017
MA Period of Validity unlimited
MA Revocation Date 07.05.2018*
Classification Number UP/I-530-09/16-02/229
Registration Number 381-12-01/70-17-05
Composition jedna sublingvalna tableta sadrži 400 mikrograma fentanila (u obliku citrata)
Prescription na recept
Type of prescription poseban recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code N02AB03
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Educational materials
for healthcare professionals
Vodič za propisivače, verzija 2
Vodič za farmaceute, verzija 2
Educational materials
for patients / caregivers
Vodič za bolesnike i njegovatelje, verzija 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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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