EMEA-002475-PIP04-23 - paediatric investigation plan

spesolimab

Key facts

• Invented name:
  Spevigo
• Active substance:
  spesolimab
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0157/2024
• PIP number:
  EMEA-002475-PIP04-23
• Pharmaceutical form(s):
  • Solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of hidradenitis suppurativa
• 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:
  06/05/2024
• Compliance check done:
  Nie

Decision

P/0157/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for spesolimab (Spevigo), (EMEA-002475-PIP04-23)

Adopted Reference Number: EMA/170629/2024