EMEA-001782-PIP01-15-M03 - paediatric investigation plan

Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage

Key facts

• Invented name:
  Influvac Tetra
• Active substance:
  Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage
• Therapeutic area:
  Vaccines
• Decision number:
  P/0211/2018
• PIP number:
  EMEA-001782-PIP01-15-M03
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of influenza infection
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/07/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001782-PIP01-15-M03
• Compliance opinion date:
  04/09/2020
• Compliance outcome:
  Positive

Decision

P/0211/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata linea

Adopted Reference Number: EMA/465552/2018