EMA/PE/0000234339 - paediatric investigation plan

SARS-CoV-2, spike protein, recombinant, expressed in Sf9 cells derived from Spodoptera frugiperda

Key facts

• Invented name:
  Nuvaxovid
• Active substance:
  SARS-CoV-2, spike protein, recombinant, expressed in Sf9 cells derived from Spodoptera frugiperda
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000234339
• PIP number:
  EMA/PE/0000234339
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  No

Decision

EMA/PE/0000234339 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for SARS-CoV-2, spike protein, recombinant, expressed in Sf9 cells derived from Spodoptera frugiperda (Nuvaxovid)

Adopted Reference Number: EMADOC-1700519818-2037296