STN: BL 125127
Proper Name: Influenza Virus Vaccine
Tradename: Fluarix Quadrivalent
Manufacturer: GlaxoSmithKline Biologicals
- For active immunization of persons 3 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
- November 18, 2016 Summary Basis for Regulatory Action - Fluarix and Fluarix Quadrivalent (PDF - 200KB)
November 18, 2016 Approval Letter - Fluarix Quadrivalent(PDF - 41KB)
To include Clinical Data to support harmonization of the monovalent bulk manufacturing process at Dresden manufacturing facility.
July 1, 2016 Approval Letter - Fluarix Quadrivalent(PDF - 49KB)
To include the 2016-2017 United State Formulation.
June 27, 2014 Approval Letter - Fluarix Quadrivalent
To include the 2014-2015 United States formulation.
June 28, 2013 Approval Letter - Fluarix Quadrivalent
To include the 2013-2014 United States formulation.
December 14, 2012 Approval Letter- Fluarix Quadrivalent
To include a quadrivalent influenza virus vaccine formulation for use in persons 3 years of age and older.
November 30, 2012 - Summary Basis of Regulatory Action -Fluarix Quadrivalent(PDF - 358KB) Statistical Review and Evaluation - Fluarix® Quadrivalent(PDF - 2.4MB) Clinical Review - Fluarix Quadrivalent(PDF - 817KB)