EMEA-003640-PIP01-24 - paediatric investigation plan

recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)

recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)

recombinant influenza hemagglutinin-strain B (RIV3)

Key facts

• Active substance:
  • recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • recombinant influenza hemagglutinin-strain B (RIV3)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0220/2024
• PIP number:
  EMEA-003640-PIP01-24
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Prevention of influenza
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/06/2024
• Compliance check done:
  No

Decision

P/0220/2024 : EMA decision of 14 June 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for recombinant influenza hemagglutinin-strain A (H1N1 subtype).....(EMEA-003640-PIP01-24)

Adopted Reference Number: EMA/272023/2024