EMEA-002418-PIP01-18-M02 - 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:
  Vaccines
• Decision number:
  P/0100/2022
• PIP number:
  EMEA-002418-PIP01-18-M02
• 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:
  18/03/2022

Decision

P/0100/2022 : EMA decision of 18 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant influenza hemagglutinin-strain A (H1N1 subtype)/recombinant influenza...(EMEA-002418-PIP01-18-M02)

AdoptedReference Number: EMA/149054/2022