EMEA-001776-PIP04-17-M01 - paediatric investigation plan

Risankizumab

Key facts

• Invented name:
  Skyrizi
• Active Substance:
  Risankizumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0391/2023
• PIP number:
  EMEA-001776-PIP04-17-M01
• 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:
  13/09/2023

Decision

P/0391/2023: EMA decision of 13 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for risankizumab (Skyrizi), (EMEA-001776-PIP04-17-M01)

Reference Number: EMA/412625/2023