Delirium schreef op 25 januari 2021 13:24:
www.ema.europa.eu/en/documents/agenda...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.
Committee for medicinal products for human use (CHMP)
EMA/CHMP/47240/2021 Page 25/41
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
Leaflet.”
Action: For adoption