EMA/PE/0000232930 - paediatric investigation plan

mirikizumab

Key facts

• Invented name:
  Omvoh
• Active substance:
  mirikizumab
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  EMA/PE/0000232930
• PIP number:
  EMA/PE/0000232930
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  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:
  28/01/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000232930 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for mirikizumab (Omvoh)

Adopted Reference Number: EMADOC-1700519818-1855569