EMEA-001776-PIP01-15-M01 - paediatric investigation plan

risankizumab

Key facts

• Invented name:
  Skyrizi
• Active substance:
  risankizumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0497/2022
• PIP number:
  EMEA-001776-PIP01-15-M01
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
  • Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of psoriasis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/12/2022
• Compliance check done:
  Tá
• Compliance procedure number:
  EMA/PE/0000285122
• Compliance opinion date:
  12/09/2025
• Compliance outcome:
  Positive

Decision

P/0497/2022 : EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for risankizumab (Skyrizi), (EMEA-001776-PIP01-15-M01)

Adopted Reference Number: EMA/853256/2022