EMEA-002208-PIP01-17-M03 - paediatric investigation plan

Mirikizumab

Key facts

• Invented name:
  Omvoh
• Active Substance:
  Mirikizumab
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0534/2023
• PIP number:
  EMEA-002208-PIP01-17-M03
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  • Treatment of Crohn's disease
  • Treatment of ulcerative colitis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023

Decision

P/0534/2023: EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for mirikizumab (Omvoh), (EMEA-002208-PIP01-17-M03)

Reference Number: EMA/562674/2023