EMA/PE/0000228512 - paediatric investigation plan

satralizumab

Key facts

• Invented name:
  Enspryng
• Active substance:
  satralizumab
• Decision number:
  P/0028/2023
• PIP number:
  EMA/PE/0000228512
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of autoimmune encephalitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  Ne

Decision

P/0028/2023 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for satralizumab (Enspryng) (EMA/PE/0000228512)

Adopted Reference Number: EMADOC-1700519818-2033503