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
Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting
"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.
Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.
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