EMEA-002893-PIP01-20-M03 - paediatric investigation plan

elasomeran

imelsomeram

davesomeran

Key facts

• Invented name:
  Spikevax (previously COVID-19 Vaccine Moderna)
• Active Substance:
  • elasomeran
  • imelsomeram
  • davesomeran
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0152/2023
• PIP number:
  EMEA-002893-PIP01-20-M03
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Moderna Biotech Spain, S.L; E-mail: [e-mail] ; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/04/2023

Decision

P/0152/2023 : EMA decision of 24 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for elasomeran (Spikevax), elasomeran/imelsomeram and elasomeran/davesomeran, (EMEA-002893-PIP01-20-M03)

Reference Number: EMA/177614/2023