EMA/PE/0000227301 - paediatric investigation plan

mRNA encoding Influenza A, H1N1 strain, hemagglutinin glycoprotein, mRNA encoding Influenza A, H3N2 strain, hemagglutinin glycoprotein, mRNA encoding Influenza B/Victoria, hemagglutinin glycoprotein, mRNA-1283

Key facts

• Active substance:
  mRNA encoding Influenza A, H1N1 strain, hemagglutinin glycoprotein, mRNA encoding Influenza A, H3N2 strain, hemagglutinin glycoprotein, mRNA encoding Influenza B/Victoria, hemagglutinin glycoprotein, mRNA-1283
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000227301
• PIP number:
  EMA/PE/0000227301
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Prevention of influenza and coronavirus 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:
  20/09/2024
• Compliance check done:
  No

Decision

EMA/PE/0000227301 : EMA decision of 20 September 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mRNA encoding Influenza A, H1N1 strain, ... (EMA/PE/0000227301)

Adopted Reference Number: EMADOC-1700519818-1683151