EMEA-002893-PIP01-20-M02 - paediatric investigation plan

Elasomeran / imelasomeran Elasomeran

Key facts

• Invented name:
  • Spikevax
  • Spikevax (previously COVID-19 Vaccine Moderna)
• Active Substance:
  Elasomeran / imelasomeran Elasomeran
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0256/2022
• PIP number:
  EMEA-002893-PIP01-20-M02
• 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:
  30/06/2022

Decision

P/0256/2022 : EMA decision of 30 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for elasomeran (Spikevax) and elasomeran/imelsomeram (EMEA-002893-PIP01-20-M02)

Reference Number: EMA/612853/2022