Afluria, Afluria Southern Hemisphere

STN: BL 125254
Proper Name: Influenza Vaccine
Tradename: Afluria, Afluria Southern Hemisphere
Manufacturer: Seqirus Pty. Ltd.
Indication:

• 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

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

Supporting Documents

• 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