EMEA-003603-PIP01-24 - paediatric investigation plan

split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain/Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain/Split influenza virus, inactivated containing antigens equivalent to B-like strain

Key facts

• Active substance:
  split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain/Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain/Split influenza virus, inactivated containing antigens equivalent to B-like strain
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0088/2024
• PIP number:
  EMEA-003603-PIP01-24
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of influenza
• Route(s) of administration:
  • Subcutaneous use
  • Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/03/2024
• Compliance check done:
  No

Decision

P/0088/2024 : EMA decision of 15 March 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for split influenza virus... (EMEA-003603-PIP01-24)

Adopted Reference Number: EMA/111601/2024