EMEA-001625-PIP02-21-M03 - paediatric investigation plan

satralizumab

Key facts

• Invented name:
  Enspryng
• Active substance:
  satralizumab
• Therapeutic area:
  • Nervous system disorders
  • Neurology
• Decision number:
  P/0069/2024
• PIP number:
  EMEA-001625-PIP02-21-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/03/2024
• Compliance check done:
  Nein

Decision

P/0069/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for satralizumab (Enspryng), (EMEA-001625-PIP02-21-M03)

Adopted Reference Number: EMA/77109/2024