EMEA-002941-PIP01-20-M05 - 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:
  Infections and infestations
• Decision number:
  P/0255/2024
• PIP number:
  EMEA-002941-PIP01-20-M05
• 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:
  19/07/2024
• Compliance check done:
  No

Decision

P/0255/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed PIP for severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (Nuvaxovid), (EMEA-002941-PIP01-20-M05)

Adopted Reference Number: EMA/296650/2024