EMA/PE/0000274326 - paediatric investigation plan

risankizumab

Key facts

• Invented name:
  Skyrizi
• Active substance:
  risankizumab
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0492/2023
• PIP number:
  EMA/PE/0000274326
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/10/2025
• Compliance check done:
  No

Decision

EMA/PE/0000274326: EMA decision of 31 October 2025 on the acceptance of a modification of an agreed paediatric investigation plan for risankizumab (Skyrizi)

Adopted Reference Number: EMADOC-1700519818-2525361