EMEA-000599-PIP01-09-M07 - paediatric investigation plan

Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1)

Key facts

• Invented name:
  Aflunov
• Active substance:
  Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0189/2020
• PIP number:
  EMEA-000599-PIP01-09-M07
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of influenza
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2020
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000599-PIP01-09-M07
• Compliance opinion date:
  26/05/2023
• Compliance outcome:
  Positive

Decision

P/0189/2020: EMA decision of 15 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1) (Aflunov and associated names), (EMEA-000599- PIP01-09-M07)

Adopted Reference Number: EMA/233132/2020