STN: BL 125127
Proper Name: Influenza Vaccine
Tradename: Fluarix Quadrivalent
Manufacturer: Glaxosmithkline Biologicals
Indication:

• FLUARIX QUADRIVALENT is a vaccine indicated for active immunization against influenza in individuals 6 months and older.

Product Information

• Package Insert - Fluarix Quadrivalent

Supporting Documents

• March 1, 2023 Approval Letter - Fluarix Quadrivalent
• July 1, 2022 Approval Letter - Fluarix Quadrivalent
• July 2, 2021 Approval Letter - Fluarix
• July 2, 2020 Approval Letter - Fluarix Quadrivalent
• March 20, 2020 Approval Letter - Fluarix Quadrivalent
• July 2, 2019 - Approval Letter - Fluarix Quadrivalent
• June 29, 2018 Approval Letter - Fluarix Quadrivalent
  To include the 2018-2019 United State formulation and associated labeling revisions.
• March 16, 2018 Approval Letter - Fluarix Quadrivalent
  To include revised Prescribing Information incorporating post-marketing surveillance safety updates in the section of Post-marketing data.
• Clinical Review (STN: 125127/834) - Fluarix Quadrivalent
• Statistical Review (STN: 125127/834) - Fluarix Quadrivalent
• January 11, 2018 SBRA Fluarix Quadrivalent
• January 11, 2018 Approval Letter - Fluarix Quadrivalent
  To extend the age range for use of Fluarix Quadrivalent to include children 6 to 35 months of age.
• July 7, 2017 Approval Letter - Fluarix Quadrivalent
  To include the 2017-2018 United States formulation and associated labeling revisions.
• Supporting Documents older than three years - Fluarix Quadrivalent