Extension of indication to include treatment of active moderate to severe hidradenitis suppurativa in adolescents 12 years and older with an inadequate response to conventional systemic HS therapy for Cosentyx, based on modelling and extrapolation of existing data. (European Medicines Agency) - Oct 2, 2026 - Pharmacovigilance Risk
Assessment Committee (PRAC)-Draft agenda for the meeting on 28 Sep – 1 Oct 2026:
As a consequence, sections 4.1, 4.2, 5.1 and 5.2 of the SmPC are
updated. The Package Leaflet is updated in accordance. Version 14.0 of the RMP
has also been submitted. [AI generated summary]
PRAC • Hidradenitis Suppurativa • Immunology
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