EMEA-002925-PIP01-20-M02 - paediatric investigation plan

cilgavimab (AZD1061)

Key facts

• Invented name:
  Evusheld
• Active substance:
  cilgavimab (AZD1061)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0460/2023
• PIP number:
  EMEA-002925-PIP01-20-M02
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  • Prevention or treatment of COVID-19
  • Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  • Intramuscular use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023
• Compliance check done:
  Non

Decision

P/0460/2023 : EMA decision of of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cilgavimab (Evusheld), (EMEA-002925-PIP01-20-M02)

Adopted Reference Number: EMA/526329/2023