EMEA-003641-PIP01-24 - paediatric investigation plan

purified antigen fractions of inactivated split virion influenza virus type A, H1N1

influenza virus type A, H3N2

influenza virus type B, Victoria lineage

Key facts

• Active substance:
  • purified antigen fractions of inactivated split virion influenza virus type A, H1N1
  • influenza virus type A, H3N2
  • influenza virus type B, Victoria lineage
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0219/2024
• PIP number:
  EMEA-003641-PIP01-24
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of influenza infection
• 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:
  13/06/2024
• Compliance check done:
  No

Decision

P/0219/2024 : EMA decision of 13 June 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for purified antigen fractions of inactivated split virion influenza virus type A, H1N1 (EMEA-003641-PIP01-24)

Adopted Reference Number: EMA/255062/2024