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 QUADRIVALENT SOUTHERN HEMISPHERE : is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT SOUTHERN HEMISPHERE is approved for use in persons 6 months of age and older.
• Afluria Quadrivalent: is an inactivated influenza vaccine indicated for 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

• Package Insert - AFLURIA QUADRIVALENT
• Package Insert - AFLURIA QUADRIVALENT SOUTHERN HEMISPHERE

Supporting Documents

• March 23, 2026 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
• 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