EMEA-003079-PIP01-22 - paediatric investigation plan

tixagevimab

cilgavimab

Key facts

• Invented name:
  Evusheld
• Active Substance:
  • tixagevimab
  • cilgavimab
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0119/2023
• PIP number:
  EMEA-003079-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Prevention of Coronavirus disease 2019 (COVID-19)
  • Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  • Intramuscular use
  • Intravenous use
• Contact for public enquiries:

  AstraZeneca AB

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/04/2023

Decision

P/0119/2023 : EMA decision of 13 April 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for tixagevimab / cilgavimab (Evusheld), (EMEA-003079-PIP01-22)

AdoptedReference Number: EMA/103747/2023