STN: BL 125254
Proper Name: Influenza Vaccine
Tradename: Afluria, Afluria Southern Hemisphere
Manufacturer: Seqirus Pty. Ltd.
Indication:
- Afluria: For active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.
- Afluria Southern Hemisphere is an inactivated influenza vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.
AFLURIA SOUTHERN HEMISPHERE is approved for use in persons 6 months of age and older.
Product Information
Supporting Documents
- March 14, 2025 Approval Letter – AFLURIA
- July 1, 2024 Approval Letter – AFLURIA
- March 1, 2024 Approval Letter – AFLURIA
- February 1, 2024 Approval Letter – AFLURIA
- January 26, 2024 Approval Letter – Afluria Trivalent and Afluria Quadrivalent
- June 30, 2023 Approval Letter – Afluria (trivalent) and Afluria Quadrivalent
- April 7, 2023 Approval Letter – AFLURIA
- July 1, 2022 Approval Letter – Afluria and Afluria Quadrivalent
- February 17, 2022 Approval Letter – AFLURIA
- February 8, 2021 Approval Letter – Afluria
- August 27, 2020 Approval Letter – Afluria
- January 23, 2020 Approval Letter – Afluria and Afluria Quadrivalent
- December 23, 2019 Approval Letter – Afluria and Afluria Quadrivalent
- October 4, 2018 Approval Letter – AFLURIA
To extend the indication for use to persons 6 through 59 months of age. - July 13, 2018 Approval Letter – AFLURIA
To include the 2018-2019 United States formulation and associated labeling revisions. - July 14, 2017 Approval Letter – AFLURIA
To include the 2017-2018 United States formulation and associated labeling revisions. - Supporting Documents older than three years – AFLURIA
- Approval History, Letters, Reviews, and Related Documents – AFLURIA
Related Information
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Content current as of:
03/14/2025
