EMEA-003556-PIP01-23 - paediatric investigation plan

tulisokibart

Key facts

• Active substance:
  tulisokibart
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0390/2024
• PIP number:
  EMEA-003556-PIP01-23
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

P/0390/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tulisokibart, (EMEA-003556-PIP01-23)

Adopted Reference Number: EMA/552717/2024