EMEA-003589-PIP01-24 - paediatric investigation plan

influenza virus type B, Victoria lineage

Influenza A virus subtype H3N2 haemagglutinin, recombinant

Influenza A virus subtype H1N1 haemagglutinin, recombinant

Key facts

• Active Substance:
  • influenza virus type B, Victoria lineage
  • Influenza A virus subtype H3N2 haemagglutinin, recombinant
  • Influenza A virus subtype H1N1 haemagglutinin, recombinant
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0045/2024
• PIP number:
  EMEA-003589-PIP01-24
• Pharmaceutical form(s):
  Nasal spray suspension
• Condition(s) / indication(s):
  Prevention of influenza infection
• Route(s) of administration:
  Nasal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/02/2024

Decision

P/0045/2024 : EMA decision of 9 February 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for influenza Virus Type B, Victoria lineage / Influenza Virus Type A, H3N2 / Influenza Virus Type A, H1N1 (EMEA-003589- PIP0

AdoptedReference Number: EMA/57360/2024