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 | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | L04AF04 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| 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 |
Packaging
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. |
