Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere
STN: BL 125254
Proper Name: Influenza Vaccine
Tradename: Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere
Manufacturer: Seqirus Pty Ltd.
Indication:
- Afluria: Active immunization against influenza disease cause by influenza virus subtypes A and type B present in the vaccine. Afluria is approved for use in persons 6 months of age and older.
- Afluria Quadrivalent: Active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Afluria Quadrivalent is approved for use in persons 6 months of age and older.
Product Information
Supporting Documents
- 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
- July 2, 2021 Approval Letter - AFLURIA
- March 4, 2021 Approval Letter - Afluria Quadrivalent
- February 8, 2021 Approval Letter - Afluria
- August 27, 2020 Approval Letter - Afluria
- July 2, 2020 Approval Letter - Afluria
- January 23, 2020 Approval Letter - Afluria and Afluria Quadrivalent
- December 23, 2019 Approval Letter - Afluria and Afluria Quadrivalent
- July 2, 2019 Approval Letter - Afluria
- Clinical Review - Afluria Quadrivalent (125254-692)
- Statistical Review - Afluria Quadrivalent (125254-692)
- Statistical Review Addendum - Afluria Quadrivalent (125254-692)
- October 3, 2018 Summary Basis for Regulatory Action - Afluria Quadrivalent
- October 4, 2018 Approval Letter - Afluria and Afluria Quadrivalent
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. - August 31, 2017 Clinical Review - Afluria Quadrivalent
- August 31, 2017 Statistical Review - Afluria Quadrivalent
- August 31, 2017 Approval Letter - AFLURIA QUADRIVALENT
To extend the indication for use in persons 5 years and older. - August 29, 2017 Summary Basis for Regulatory Action - Afluria Quadrivalent
- July 14, 2017 Approval Letter - AFLURIA QUADRIVALENT
To include the 2017-2018 United States formulation and associated labeling revisions. - Supporting Documents older than three years - AFLURIA QUADRIVALENT