Proper Name: Influenza Virus Vaccine
Manufacturer: Novartis Vaccines and Diagnostics, Inc.
For active immunization of persons 18 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
July 2, 2015 Approval Letter - Flucelvax(PDF - 28KB)
To Include the 2015 - 2016 United States formulation and corresponding labeling.
April 2, 2015 Approval Letter - Flucelvax(PDF - 33KB)
To include changes to the package insert.
June 27, 2014 Appoval Letter - Flucelvax
To include the 2014-2015 United States formulation.
June 20, 2014 Approval Letter - Flucelvax
To revise the package insert by adding generalized skin reactions including prutitus, urticaria or non-specific rash to section 6.2, post marketing experience with Flucelvax.
September 6, 2013 Approval Letter - Flucelvax
To revise the package insert by adding reports of anaphylaxis or angioedema to Section 6.2, Postmarketing Experience with Flucelvax, and making other minor editorial changes, has been date stamped and issued.
July 19, 2013 Approval Letter - Flucelvax
To include the 2013-2014 United States Formulation.
November 20, 2012 Approval Letter- Flucelvax Summary Basis of Regulatory Action, November 20, 2012 - Flucelvax(PDF - 229KB) Approval History, Letters, Reviews, and Related Documents - Flucelvax