Afluria, Afluria Southern Hemisphere
STN: BL 125254
Proper Name: Influenza Vaccine
Tradename: Afluria, Afluria 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 Southern Hemisphere is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
Afluria Southern Hemisphere is approved for use in persons 6 months of age and older.
Product Information
Supporting Documents
- 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
- Dear Health Care Professional Letter - AFLURIA - ARCHIVED
July 2014 - FDA Expands Use of CSL Limited's Seasonal and H1N1 Vaccines to Infants and Children - ARCHIVED