EMEA-003184-PIP01-22 - paediatric investigation plan

AV2-cVLP-RBD SARS-CoV-2 (ABNCoV2)

Key facts

• Active Substance:
  AV2-cVLP-RBD SARS-CoV-2 (ABNCoV2)
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0139/2023
• PIP number:
  EMEA-003184-PIP01-22
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/04/2023

Decision

P/0139/2023 : EMA decision of 14 April 2023 on on the agreement of a paediatric investigation plan and on the granting of a deferral for AV2-cVLP-RBD SARS-CoV-2 (ABNCoV2), (EMEA-003184-PIP01-22)

AdoptedReference Number: EMA/108918/2023