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
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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Content current as of:
03/24/2026
