EMEA-002418-PIP01-18-M04 - paediatric investigation plan

recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)

recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)

recombinant Influenza Hemagglutinin-strain B (Victoria lineage)

recombinant Influenza Hemagglutinin-strain B (Yamagata lineage) (RIV4)

Key facts

• Invented name:
  Supemtek Tetra (previously Supemtek)
• Active substance:
  • recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • recombinant Influenza Hemagglutinin-strain B (Victoria lineage)
  • recombinant Influenza Hemagglutinin-strain B (Yamagata lineage) (RIV4)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0218/2024
• PIP number:
  EMEA-002418-PIP01-18-M04
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• 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:
  13/06/2024
• Compliance check done:
  No

Decision

P/0218/2024 : EMA decision of 13 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant influenza hemagglutinin-strain A......(Yamagata lineage) (RIV4) (Supemtek)(EMEA-002418-PIP01-18-M04)

Adopted Reference Number: EMA/255064/2024