EMEA-002880-PIP01-20-M01 - paediatric investigation plan

COVID-19 vaccine (Ad26.COV2-S (recombinant))

Key facts

• Invented name:
  Jcovden (previously COVID-19 Vaccine Janssen)
• Active substance:
  COVID-19 vaccine (Ad26.COV2-S (recombinant))
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0542/2022
• PIP number:
  EMEA-002880-PIP01-20-M01
• Pharmaceutical form(s):
  Suspension for injection in cartridge
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022
• Compliance check done:
  No

Decision

P/0542/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for COVID-19 vaccine (Ad26.COV2-S [recombinant]) (JCOVDEN) (EMEA-002880-PIP01-20-M01)

Adopted Reference Number: EMA/876009/2022