STN: 103914
Proper Name: Influenza Vaccine
Tradename: Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Fluzone High-Dose Quadrivalent Southern Hemisphere
Manufacturer: Sanofi Pasteur Inc.
Indication:
- Fluzone High-Dose Quadrivalent: A vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.
- Fluzone High-Dose Quadrivalent Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. It is approved for use in persons 65 years of age and older.
- Fluzone Quadrivalent : A vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus 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 is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Product Information
Supporting Documents
- September 26, 2024 Approval Letter – Fluzone High-Dose Quadrivalent Southern Hemisphere
- July 1, 2024 Approval Letter- Fluzone and Fluzone High-Dose
- February 14, 2024 Approval Letter – Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent Southern Hemisphere
- November 29, 2023 Approval Letter – Fluzone
- July 12, 2023 Approval Letter – Fluzone Quadrivalent and Fluzone High-Dose
- February 22, 2023 Approval Letter – Fluzone High Dose Quadrivalent
- February 13, 2023 Approval Letter – Fluzone Quadrivalent Southern Hemisphere and Fluzone High-Dose Quadrivalent Southern Hemisphere
- November 2, 2022 Approval Letter – Fluzone Quadrivalent and Fluzone Quadrivalent Southern Hemisphere
- July 1, 2022 Approval Letter – Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent
- 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
Related Information
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Content current as of:
09/27/2024
