EMEA-002359-PIP01-18-M05 - paediatric investigation plan

Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain

Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain

Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage)

Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)

Key facts

• Invented name:
  Efluelda
• Active Substance:
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage)
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0219/2022
• PIP number:
  EMEA-002359-PIP01-18-M05
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of influenza infection
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Sanofi Pasteur

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/06/2022

Decision

P/0219/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, ... (EMEA-002359-PIP01-18-M05)

Reference Number: EMA/563099/2022