EMEA-002862-PIP01-20-M02 - paediatric investigation plan

COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)

Key facts

• Invented name:
  Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
• Active Substance:
  COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0559/2021
• PIP number:
  EMEA-002862-PIP01-20-M02
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  AstraZeneca AB

  Tel. [phone]

  E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/12/2021

Decision

P/0559/2021 : EMA decision of 27 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for COVID-19 vaccine (ChAdOx1-S [recombinant]) (Vaxzevria), (EMEA-002862-PIP01-20-M02)

AdoptedReference Number: EMA/707190/2021