EMEA-003267-PIP02-23 - paediatric investigation plan

Influenza virus Type A H3N2, whole virion, inactivated

Influenza virus Type B, whole virion, inactivated

Influenza virus Type A H1N1, whole virion, inactivated

Key facts

• Active substance:
  • Influenza virus Type A H3N2, whole virion, inactivated
  • Influenza virus Type B, whole virion, inactivated
  • Influenza virus Type A H1N1, whole virion, inactivated
• Therapeutic area:
  Vaccines
• Decision number:
  P/0245/2023
• PIP number:
  EMEA-003267-PIP02-23
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of influenza
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/07/2023
• Compliance check done:
  No

Decision

P/0245/2023 : EMA decision of 14 July 2023 on refusal of PIP and on granting of waiver for influenza virus Type A H3N2, whole virion, inactivated / influenza virus Type B, whole virion, inactivated / influenza virus Type A H1N1, whole virion, inactivated

Reference Number: EMA/300235/2023