EMEA-002893-PIP01-20-M04 - paediatric investigation plan

elasomeran

imelsomeram

davesomeran

Key facts

• Invented name:
  Spikevax (previously COVID-19 Vaccine Moderna)
• Active substance:
  • elasomeran
  • imelsomeram
  • davesomeran
• Therapeutic area:
  Vaccines
• Decision number:
  P/0373/2023
• PIP number:
  EMEA-002893-PIP01-20-M04
• 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:
  08/09/2023
• Compliance check done:
  No

Decision

P/0373/2023: EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for elasomeran, elasomeran / imelasomeran, elasomeran / davesomeran, andusomeran (Spikevax), (EMEA-002893- PIP01-20-M04)

Adopted Reference Number: EMA/384557/2023