EMA/PE/0000254020 - paediatric investigation plan

risankizumab

Key facts

• Invented name:
  Skyrizi
• Active substance:
  risankizumab
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0391/2023
• PIP number:
  EMA/PE/0000254020
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Concentrate for solution for injection
  • Age appropriate dosage form for parenteral use
• 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:
  27/06/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000254020: EMA decision of 27 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for risankizumab (Skyrizi)

Adopted Reference Number: EMADOC-1700519818-2223385