EMEA-002068-PIP01-16-M05 - paediatric investigation plan

influenza vaccine (surface antigen, inactivated, prepared in cell cultures) [QIVc]

Key facts

• Invented name:
  Flucelvax Tetra
• Active substance:
  influenza vaccine (surface antigen, inactivated, prepared in cell cultures) [QIVc]
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0168/2024
• PIP number:
  EMEA-002068-PIP01-16-M05
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of influenza
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/05/2024
• Compliance check done:
  No

Decision

P/0168/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for influenza vaccine (surface antigen, inactivated, prepared in cell cultures) [QIVc] (Flucelvax Tetra), (EMEA-002068- PIP01-16-M05)

Adopted Reference Number: EMA/178725/2024