EMEA-003318-PIP01-22 - paediatric investigation plan

modRNA encoding 4 influenza HA antigens (2 for influenza A and 2 for influenza B strains) (qIRV)

Key facts

• Active Substance:
  modRNA encoding 4 influenza HA antigens (2 for influenza A and 2 for influenza B strains) (qIRV)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0255/2023
• PIP number:
  EMEA-003318-PIP01-22
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Prevention of influenza
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Pfizer Europa MA EEIG

  Email: [e-mail]; Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/07/2023

Decision

P/0255/2023 : EMA decision of 14 July 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modRNA encoding 4 influenza HA antigens (2 for influenza A and 2 for influenza B strains)

Reference Number: EMA/304055/2023