Jyseleca 100 mg and 200 mg film-coated tablets *

Pharmacy Only: Prescription

Approval of extension of indication to include use of Jyseleca for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

The variation updates the product information extensively as follows:

•    SmPC updates to sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 5.3

•    Consequential updates to the Package Leaflet sections 1, 2 and 3

The MAH also took the opportunity to make minor updates to the Annex II and to implement minor editorial changes in the SmPC and Package Leaflet
 

Approval of extension of indication to include use of Jyseleca for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

The variation updates the product information extensively as follows: SmPC updates to sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 5.3

In line with the changes to SmPC sections 4.5 and 5.2 in order to reflect new pharmacokinetic information on the effect of filgotinib on OATP/CYP3A, OATP/BCRP, and OATP substrates based on final results from study GS-US-417-5937; this is a Phase 1, randomized, two-way crossover, open-label, single and multiple dose, single center study to evaluate the effect of filgotinib on a mixed OATP/CYP3A, OATP/BCRP, and OATP substrates using phenotypic probes; the Package Leaflet is updated accordingly. Update of sections 4.5 and 5.2 of the SmPC in order to reflect new pharmacokinetic information on the effect of filgotinib on OATP/CYP3A, OATP/BCRP, and OATP substrates based on final results from study GS-US-417-5937; this is a Phase 1, randomized, two-way crossover, open-label, single and multiple dose, single center study to evaluate the effect of filgotinib on a mixed OATP/CYP3A, OATP/BCRP, and OATP substrates using phenotypic probes; the Package Leaflet is updated accordingly.