EMEA-002475-PIP03-22-M01 - paediatric investigation plan

spesolimab

Key facts

• Invented name:
  Spevigo
• Active substance:
  spesolimab
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0341/2024
• PIP number:
  EMEA-002475-PIP03-22-M01
• Pharmaceutical form(s):
  • Solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of Netherton syndrome
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0341/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for spesolimab (Spevigo), (EMEA-002475-PIP03-22-M01)

Adopted Reference Number: EMA/410240/2024