EMA/PE/0000228531 - paediatric investigation plan

elasomeran

imelsomeram

davesomeran

andusomeran SARS-CoV-2 JN.1 mRNA

Key facts

• Invented name:
  Spikevax (previously COVID-19 Vaccine Moderna)
• Active substance:
  • elasomeran
  • imelsomeram
  • davesomeran
  • andusomeran SARS-CoV-2 JN.1 mRNA
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0373/2023
• PIP number:
  EMA/PE/0000228531
• 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:
  20/03/2025
• Compliance check done:
  No

Decision

EMA/PE/0000228531: EMA decision of 20 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for davesomeran, elasomeran, imelasomeran, andusomeran, SARS-CoV-2 JN.1 mRNA (Spikevax bivalent Original/Omicron BA.1, Spikevax

Adopted Reference Number: EMADOC-1700519818-1993726