EMA/PE/0000189672 - paediatric investigation plan

obefazimod

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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/03/2025
• Compliance check done:
  Nej

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