EMA/PE/0000232763

## Key facts Active substance icotrokinra Therapeutic area Musculoskeletal and connective tissue disorders Decision number EMA/PE/0000232763 PIP number EMA/PE/0000232763 Pharmaceutical form(s) Film-coated tablet Age-appropriate oral dosage form Condition(s) / indication(s) Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis) Route(s) of administration Oral use Contact for public enquiries Janssen Cilag International Email: contact@Janssen-emea.com Tel. +32 14602111 Decision type P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Decision date 20/03/2025 Compliance check done No ## Decision EMA/PE/0000232763 : EMA decision of 20 March 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for icotrokinra Adopted Reference Number: EMADOC-1700519818-1976511 English (EN) (219.56 KB - PDF) First published: 04/06/2026 View