An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Vaccines

Fluarix

STN: BL 125127
Proper Name: Influenza Virus Vaccine
Tradename: Fluarix
Manufacturer: GlaxoSmithKline Biologicals
Indication:

For active immunization of persons 3 years of age and older for the prevention of disease caused by influenza virus subtypes A and type B contained in the vaccine.

Product Information

Package Insert - Fluarix

Supporting Documents

November 18, 2016 Summary Basis for Regulatory Action - Fluarix
November 18, 2016 Approval Letter - Fluarix
To include clinical data to support harmonization of the monovalent bulk manufacturing process at your Dresden manufacturing facility.
June 30, 2015 Approval Letter - Fluarix
To include 2015 - 2016 United States formulation.
Supporting Documents older than three years - Fluarix

Content current as of:

02/26/2018
Regulated Product(s)
- Biologics
- Vaccines