EMEA-003521-PIP01-23 - paediatric investigation plan

single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A/H1N1, A/H3N2, and B/Victoria and the N-terminal domain (NTD) and receptor binding domain (RBD) of the SARS-CoV-2 spike glycoprotein (mRNA-1083)

Key facts

• Active substance:
  single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A/H1N1, A/H3N2, and B/Victoria and the N-terminal domain (NTD) and receptor binding domain (RBD) of the SARS-CoV-2 spike glycoprotein (mRNA-1083)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0309/2024
• PIP number:
  EMEA-003521-PIP01-23
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  • Prevention of Coronavirus disease 2019 (COVID-19)
  • Prevention of influenza
• 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:
  16/08/2024
• Compliance check done:
  No

Decision

P/0309/2024: EMA decision of 16 August 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for single-stranded 5' capped mRNA encoding... (EMEA-003521-PIP01-23)

Adopted Reference Number: EMA/364890/2024