EMA/PE/0000226753 - 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

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
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000226753
• PIP number:
  EMA/PE/0000226753
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  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:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000226753 : EMA decision of 3 January 2025 on agreement of PIP, and granting of deferral and waiver for mRNA encoding influenza A, H1N1 strain, haemagglutinin glycoprotein, mRNA encoding influenza A, H3N2 strain, haemagglutinin glycoprotein...

Adopted Reference Number: EMADOC-1700519818-1809706