EMEA-003196-PIP01-22-M01 - paediatric investigation plan

obefazimod

Key facts

• Active substance:
  obefazimod
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0205/2024
• PIP number:
  EMEA-003196-PIP01-22-M01
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral liquid dosage formulation
• 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:
  14/06/2024
• Compliance check done:
  No

Decision

P/0205/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for obefazimod (EMEA- 003196-PIP01-22-M01)

Adopted