EMEA-001776-PIP02-17-M02 - paediatric investigation plan

Risankizumab

Key facts

• Invented name:
  Skyrizi
• Active Substance:
  Risankizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0492/2023
• PIP number:
  EMEA-001776-PIP02-17-M02
• Pharmaceutical form(s):
  • Solution for injection
  • Age-appropriate pharmaceutical form
• 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:
  01/12/2023

Decision

P/0492/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for risankizumab (Skyrizi), (EMEA-001776-PIP02-17-M02)

Reference Number: EMA/530125/2023