EMA/PE/0000189672

## Key facts Active substance obefazimod Therapeutic area Gastrointestinal disorders Decision number P/0205/2024 PIP number EMA/PE/0000189672 Pharmaceutical form(s) Capsule, hard Oral solution Condition(s) / indication(s) Treatment of ulcerative colitis Route(s) of administration Oral use Contact for public enquiries Abivax E-mail: Didier.Blondel@abivax.com Tel. +33 153830839 Decision type PM: decision on the application for modification of an agreed PIP Decision date 20/03/2025 Compliance check done No ## Decision EMA/PE/0000189672: EMA decision of 20 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for obefazimod Adopted Reference Number: EMADOC-1700519818-1975045 English (EN) (256.89 KB - PDF) First published: 19/06/2026 View