EMEA-000817-PIP02-11-M01 - 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

influenza virus type B, Yamagata lineage

Key facts

• Invented name:
  Influsplit Tetra and associated names
• 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
  • influenza virus type B, Yamagata lineage
• Therapeutic area:
  Vaccines
• Decision number:
  P/0171/2013
• PIP number:
  EMEA-000817-PIP02-11-M01
• 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:
  30/07/2013
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-000817-PIP02-11-M01
• Compliance opinion date:
  21/04/2017
• Compliance outcome:
  Positive

Decision

P/0171/2013: EMA decision of 30 July on the acceptance of a modification of an agreed paediatric investigation plan for purified antigen fractions of inactivated split virion Influenza virus type A, H1N1 / Influenza viru...

Adopted Reference Number: EMA/376110/2013