EMEA-001776-PIP04-17 - paediatric investigation plan

risankizumab

Key facts

• Active substance:
  risankizumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0231/2018
• PIP number:
  EMEA-001776-PIP04-17
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • 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:
  03/08/2018
• Compliance check done:
  No

Decision

P/0231/2018: EMA decision of 3 August 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for risankizumab (EMEA-001776-PIP04-17)

Adopted Reference Number: EMA/469730/2018