EMEA-002208-PIP02-24 - paediatric investigation plan

Mirikizumab

Key facts

• Invented name:
  Omvoh
• Active substance:
  Mirikizumab
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0129/2024
• PIP number:
  EMEA-002208-PIP02-24
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/04/2024
• Compliance check done:
  No

Decision

P/0129/2024: EMA decision of 11 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mirikizumab (Omvoh) (EMEA-002208-PIP02-24)

Reference Number: EMA/142238/2024