EMEA-002941-PIP01-20-M04 - paediatric investigation plan

Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373)

Key facts

• Invented name:
  Nuvaxovid
• Active Substance:
  Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0423/2023
• PIP number:
  EMEA-002941-PIP01-20-M04
• Pharmaceutical form(s):
  Suspension for injection
• 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:
  27/10/2023

Decision

P/0423/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for severe acute respiratory syndrome coronavirus 2 recombinant spike protein......(Nuvaxovid) (EMEA-002941-PIP01-20-M04)

AdoptedReference Number: EMA/424655/2023