EMEA-001625-PIP01-14-M07 - paediatric investigation plan

satralizumab

Key facts

• Active Substance:
  satralizumab
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0519/2023
• PIP number:
  EMEA-001625-PIP01-14-M07
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of neuromyelitis optica
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023

Decision

P/0519/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for satralizumab (Enspyng), (EMEA-001625-PIP01-14-M07)

Reference Number: EMA/554543/2023