Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere
STN: 103914
Proper Name: Influenza Vaccine
Tradename: Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere
Manufacturer: Sanofi Pasteur Inc.
Indication:
- Fluzone High-Dose Quadrivalent: For active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B viruses contained in the vaccine.
- Fluzone Quadrivalent: For active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B viruses contained in the vaccine.
- Fluzone Intradermal Quadrivalent: For active immunization of persons 18 through 64 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
- Fluzone Quadrivalent Southern Hemisphere: For active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Product Information
- Package Insert - Fluzone High-Dose Quadrivalent
- Package Insert and Patient Information Sheet - Fluzone Quadrivalent
- Package Insert - Fluzone Intradermal Quadrivalent
- Package Insert and Patient Information Sheet - Fluzone Quadrivalent Southern Hemisphere
Supporting Documents
- February 14, 2022 Approval Letter - Fluzone Quadrivalent Southern Hemisphere
- September 27, 2021 Approval Letter - Fluzone Quadrivalent and Fluzone Quadrivalent Southern Hemisphere
- July 2, 2021 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent
- February 4, 2021 Approval Letter - Fluzone Quadrivalent Southern Hemisphere
- July 2, 2020 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent
- April 1, 2020 Approval Letter - Fluzone Quadrivalent
- February 7, 2020 Approval Letter - Fluzone Quadrivalent Southern Hemisphere
- November 4, 2019 Approval Letter - Fluzone High-Dose Quadrivalent
- July 2, 2019 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose
- February 4, 2019 Approval Letter - Fluzone Quadrivalent Southern Hemisphere
To include the 2019 Southern Hemisphere FluzoneQuadrivalent formulation and associated labeling revisions. - January 23, 2019 Approval Letter - Fluzone Quadrivalent
To include the use of a 0.5 mL single dose presentation of Fluzone Quadrivalent formulation in children 6 to ‹36 months of age. - January 18, 2019 Summary Basis of Regulatory Action
- Clinical Review - Fluzone Quadrivalent
- Statistical Review and Evaluation - Fluzone Quadrivalent
- June 29, 2018 Approval Letter- Fluzone-Quadrivalent
To include the 2018-2019 Northern Hemisphere formulation and associated labeling revisions. - January 10, 2018 Approval Letter - Fluzone
To include the 2018 Southern Hemisphere Formulation and Associated Labeling Revisions. - February 9, 2017 Approval Letter - Fluzone Southern Hemisphere Formulation
To include the 2017 Southern Hemisphere Formulation and Associated Labeling Revisions. - Supporting Documents older than three years - Fluzone Quadrivalent