EMA/PE/0000232315 - paediatric investigation plan

spesolimab

Key facts

• Invented name:
  Spevigo
• Active substance:
  spesolimab
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000232315
• PIP number:
  EMA/PE/0000232315
• 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:
  19/03/2025
• Compliance check done:
  No

Decision

EMA/PE/0000232315: EMA decision of 19 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for spesolimab (Spevigo)

Adopted Reference Number: EMADOC-1700519818-1976710