EMA/PE/0000223258 - paediatric investigation plan

afimkibart

Key facts

• Active substance:
  afimkibart
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  EMA/PE/0000223258
• PIP number:
  EMA/PE/0000223258
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for infusion
• Condition(s) / indication(s):
  Treatment of Crohn's disease
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/06/2025
• Compliance check done:
  Nē

Decision

EMA/PE/0000223258 : EMA decision of 12 June 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Afimkibart

Adopted Reference Number: EMADOC-1700519818-2194514