EMEA-003156-PIP02-22 - paediatric investigation plan

Efavaleukin alfa

Key facts

• Active substance:
  Efavaleukin alfa
• Therapeutic area:
  Other
• Decision number:
  P/0469/2022
• PIP number:
  EMEA-003156-PIP02-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of ulcerative colitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/11/2022
• Compliance check done:
  No

Decision

P/0469/2022: EMA decision of 14 November 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efavaleukin alfa (EMEA-003156-PIP02-22)

Adopted Reference Number: EMA/884290/2022