EMEA-001625-PIP03-21 - paediatric investigation plan

satralizumab

Key facts

• Invented name:
  Enspryng
• Active substance:
  satralizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0448/2022
• PIP number:
  EMEA-001625-PIP03-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease
• 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:
  28/10/2022
• Compliance check done:
  No

Decision

P/0448/2022 of 28 October 2022 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-PIP03-21)

Reference Number: EMA/834868/2022