Flucelvax Quadrivalent

STN: BL 125408
Proper Name: Influenza Vaccine
Tradename: Flucelvax Quadrivalent
Manufacturer: Seqirus, Inc.
Indication:

• Flucelvax Quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine.
• Flucelvax Quadrivalent is approved for use in persons 6 months of age and older.

Product Information

• Package Insert - Flucelvax Quadrivalent

Supporting Documents

• June 30, 2023 Approval Letter - Flucelvax Quadrivalent
• February 28, 2023 Approval Letter - Flucelvax
• July 1, 2022 Approval Letter - Flucelvax Quadrivalent
• Clinical Review (125408/351) - Flucelvax Quadrivalent
• Statistical Review (125408/351) - Flucelvax Quadrivalent
• October 14, 2021 Approval Letter - Flucelvax Quadrivalent
• July 2, 2021 Approval Letter - Flucelvax
• Clinical Review (STN: 125408/329) - Flucelvax Quadrivalent
• Statistical Review (STN: 125408/329) - Flucelvax Quadrivalent
• March 3, 2021 Approval Letter - Flucelvax Quadrivalent
• July 2, 2020 Approval Letter - Flucelvax
• September 18, 2019 Approval Letter - Flucelvax
• July 2, 2019 Approval Letter - Flucelvax
• April 5, 2019 Approval Letter - Flucelvax Quadrivalent
• July 20, 2018 Approval Letter - Flucelvax Quadrivalent
  To include the 2018-2019 United States formulation and associated labeling revisions.
• June 20, 2018 Approval Letter - Flucelvax Quadrivalent
  To include changes to Section 6 of the package insert based on post-marketing reports for Flucelvax Quadrivalent.
• July 7, 2017 Approval Letter - Flucelvax Quadrivalent
  To include the 2017-2018 United States formulation and associated labeling revisions.
• May 20, 2016 Clinical Review - Flucelvax Quadrivalent
• Statistical Review Addendum (STN: 125408/127) - Flucelvax Quadrivalent
• Statistical Review (STN: 125408/127) - Flucelvax Quadrivalent
• Supporting Documents older than three years - Flucelvax Quadrivalent