STN: BL 125127
Proper Name: Influenza Virus Vaccine
Manufacturer: GlaxoSmithKline Biologicals
- For active immunization of persons 3 years of age and older for the prevention of disease caused by influenza virus subtypes A and type B contained in the vaccine.
- November 18, 2016 Summary Basis for Regulatory Action - Fluarix
- November 18, 2016 Approval Letter - Fluarix
To include clinical data to support harmonization of the monovalent bulk manufacturing process at your Dresden manufacturing facility.
- June 30, 2015 Approval Letter - Fluarix
To include 2015 - 2016 United States formulation.
- Supporting Documents older than three years - Fluarix