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: [email protected] 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

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