Medicinal Products

Tacrocel 5 mg kapsule

Name Tacrocel 5 mg kapsule
Marketing Authorisation Number HR-H-855761612
Active Substance takrolimus hidrat
Composition 1 kapsula sadrži 5 mg takrolimusa u obliku takrolimus hidrata
Pharmaceutical Form kapsula, tvrda
Packaging [MA Number for Packaging] 30 kapsula u blisteru, u zaštitnoj vrećici, u kutiji  [HR-H-855761612-01]
Manufacturer Lek Pharmaceuticals d.d., Ljubljana, Slovenija;
Lek Pharmaceuticals d.d., Lendava, Slovenija;
Lek S.A., Varšava, Poljska
Marketing Authorisation Holder Sandoz d.o.o., Maksimirska 120, Zagreb
Marketing Authorisation Date 30.09.2016
MA Period of Validity unlimited
MA Revocation Date 01.02.2022*
Classification Number UP/I-530-09/15-02/471
Registration Number 381-12-01/30-16-02
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L04AD02
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Educational materials
for healthcare professionals
Brošura za zdravstvene radnike za lijek takrolimus , verzija 1
Educational materials
for patients / caregivers
Kartica za bolesnike, verzija 1

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Marketing authorisation has been revoked by request of the marketing authorisation holder.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