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: [email protected] 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

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