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In this section: Vaccines

Flucelvax Quadrivalent

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

For active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine

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

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