EMEA-003624-PIP01-24 - paediatric investigation plan

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2)

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage)

Key facts

• Active Substance:
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0180/2024
• PIP number:
  EMEA-003624-PIP01-24
• Pharmaceutical form(s):
  Suspension for injection in pre-filled syringe
• Condition(s) / indication(s):
  Prevention of influenza infection
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/05/2024

Decision

P/0180/2024: EMA decision of 16 May 2024 on the granting of a product specific waiver for influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), strain A (H3N2), strain B (Victoria lineage) (EMEA-003624-PIP01-24)

Reference Number: EMA/221881/2024