EMEA-002068-PIP01-16-M04 - paediatric investigation plan

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2)

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage)

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc]

Key facts

• Invented name:
  Flucelvax Tetra
• Active Substance:
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc]
• Therapeutic area:
  Vaccines
• Decision number:
  P/0492/2021
• PIP number:
  EMEA-002068-PIP01-16-M04
• 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:
  03/12/2021

Decision

P/0492/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin and neuraminidase) of strain... (EMEA- 002068-PIP01-16-M04)

AdoptedReference Number: EMA/627653/2021