EMEA-003426-PIP01-23 - 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/0007/2024
• PIP number:
  EMEA-003426-PIP01-23
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/01/2024

Decision

P/0007/2024 : EMA decision of 11 January 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for mRNA encoding for the linked NTD and RBD domains of the spike... (EMEA-003426-PIP01-23)

AdoptedReference Number: EMA/11071/2024