Medicinal Products

Jyseleca

The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.

Name Jyseleca
Active Substance filgotinibmaleat
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
ATC Code L04AA45
Medicinal product marketed in the Croatia Da
Summary of product characteristics (SmPC), labelling and package leaflet (PL) download
Link to the European Medicines Agency's (EMA) product information download
Link to the European Commission's (EC) decisions download
Educational materials
for healthcare professionals
Vodič za zdravstvene radnike, verzija 2
Educational materials
for patients / caregivers
Kartica za bolesnika, verzija 2

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o ažuriranim preporukama za minimizaciju rizika od malignih bolesti, velikih kardiovaskularnih štetnih događaja, ozbiljnih infekcija, venske tromboembolije i fatalnih ishoda povezanih s primjenom inhibitora Janus kinaze [Cibinqo (abrocitinib), Jyseleca (filgotinib), Olumiant (baricitinib), Rinvoq (upadacitinib) i Xeljanz (tofacitinib)] 16.03.2023 AbbVie d.o.o., Eli Lilly Hrvatska d.o.o., Swedish Orphan Biovitrum (Sobi), Pfizer Croatia d.o.o.
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