EMEA-003426-PIP01-23-M02 - paediatric investigation plan

mRNA encoding for the linked NTD and RBD domains of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)

Key facts

• Active substance:
  mRNA encoding for the linked NTD and RBD domains of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0365/2024
• PIP number:
  EMEA-003426-PIP01-23-M02
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0365/2024 : EMA decision of 25 October 2024 on acceptance of a modification of an agreed paediatric investigation plan for mRNA encoding for the linked NTD and RBD domains of the spike glycoprotein of SARS-CoV-2 (mRNA-1283), (EMEA- 003426-PIP01-23-M02)

Adopted Reference Number: EMA/482481/2024