Medicinal Products

Inzolfi 0,5 mg tvrde kapsule

Name Inzolfi 0,5 mg tvrde kapsule
Marketing Authorisation Number HR-H-552241724
Active Substance fingolimodklorid
Composition jedna tvrda kapsula sadrži 0,5 mg fingolimoda (u obliku fingolimodklorida)
Pharmaceutical Form Kapsula, tvrda
Manufacturer Novartis Pharma GmbH, Nürnberg, Njemačka
Marketing Authorisation Holder Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska
Marketing Authorisation Date 24.06.2021
MA Period of Validity 24.06.2026
MA Revocation Date 31.08.2023*
Classification Number UP/I-530-09/19-01/100
Registration Number 381-12-01/70-21-03
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L04AA27
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Public Assessment Report download
Summary of risk management plan download
Educational materials
for healthcare professionals
Lista provjere za zdravstvene radnike, verzija 5
Educational materials
for patients / caregivers
Vodič za bolesnike, verzija 5
Vodič za roditelje skrbnike, verzija 3
Kartica za bolesnice s podsjetnikom o trudnoći, verzija 1


Marketing authorisation has been revoked by request of the marketing authorisation holder.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