EMEA-001625-PIP04-22 - paediatric investigation plan

satralizumab

Key facts

• Invented name:
  Enspryng
• Active Substance:
  satralizumab
• Decision number:
  P/0028/2023
• PIP number:
  EMEA-001625-PIP04-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of autoimmune encephalitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2023

Decision

P/0028/2023 : EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for satralizumab (Enspryng), (EMEA-001625-PIP04-22)

Adopted