Proper Name: Influenza Virus Vaccine
Manufacturer: ID Biomedical Corporation of Quebec
- Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL is approved for use in persons 6 months of age and older.
- Statistical Review and Evaluation - FluLaval and FluLaval Quadrivalent
- Statistical Review Assay - FluLaval and FluLaval Quadrivalent
- Clinical Review - FluLaval and FluLaval Quadrivalent
- November 18, 2016 Summary Basis for Regulatory Action - FluLaval
- November 18, 2016 Approval Letter - FluLaval
To extend the age range for use of FluLaval and FluLaval Quadrivalent to include children 6 to 35 months of age.
- June 30, 2015 Approval Letter - FluLaval
To include the 2015 - 2016 United States formulation.
- Supporting Documents older than three years - FluLaval