Vaccines, Blood & Biologics
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.
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