EMEA-003350-PIP01-23 - paediatric investigation plan

AstraZeneca Anti-SARS-CoV-2 monoclonal antibody (AZD3152)

Key facts

• Active Substance:
  AstraZeneca Anti-SARS-CoV-2 monoclonal antibody (AZD3152)
• Therapeutic area:
  Immune system disorders
• Decision number:
  P/0504/2023
• PIP number:
  EMEA-003350-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  • Intramuscular use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/12/2023

Decision

P/0504/2023: EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for AstraZeneca Anti-SARS-CoV-2 monoclonal antibody (AZD3152), (EMEA-003350-PIP01-23)

AdoptedReference Number: EMA/528356/2023