EMA/PE/0000221589 - 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 Tetra
• 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:
  Infections and infestations
• Decision number:
  EMA/PE/0000221589
• PIP number:
  EMA/PE/0000221589
• 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:
  25/11/2024
• Compliance check done:
  No

Decision

EMA/PE/0000221589: EMA decision of 25 Nov 2024 on the acceptance of a modification of an agreed PIP for split influenza virus, inactivated containing antigens equivalent to the A/H1N1 and A/H3N2-like strain, B-like strain (Victoria / Yamagata lineage)

Adopted Reference Number: EMADOC-1700519818-1773555