EMEA-001830-PIP01-15-M02 - paediatric investigation plan

Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

Key facts

• Invented name:
  • Foclivia and associated names
  • Foclivia
• Active substance:
  Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0188/2020
• PIP number:
  EMEA-001830-PIP01-15-M02
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of influenza infection
• 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:
  Yes
• Compliance procedure number:
  EMEA-C-001830-PIP01-15-M02
• Compliance opinion date:
  16/12/2022
• Compliance outcome:
  Positive

Decision

P/0188/2020: EMA decision of 15 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (Foclivia and associated names), (EMEA- 001830-PIP01-1

Reference Number: EMA/233153/2020