5.1.9. Jyseleca - filgotinib - EMEA/H/C/005113/II/0001
Gilead Sciences Ireland UC
Rapporteur: Kristina Dunder, Co-Rapporteur: Jean-Michel Race, PRAC Rapporteur: Nikica Miroševic Skvrce
Scope: “C.I.6 (Extension of indication) C.I.6a (Extension of indication). Extension of indication to include the treatment of active ulcerative colitis in adults patients for Jyseleca. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and the Package Leaflet are updated accordingly. Version 1.1 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to do minor updates to the Annex II and to implement minor editorial changes in the SmPC and Package
Committee for medicinal products for human use (CHMP)
EMA/CHMP/276743/2021 Page 19/36
Leaflet.”
Action: For adoption