Product Approval Information

Proper Name: Influenza Virus Vaccine
Tradename: FluLaval
Manufacturer: ID Biomedical Corporation of Quebec, License #1739

Package Insert (PDF - 153 KB) - Approved: July 28, 2008

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Date: July 28, 2008
New Formulation: 2008-2009 United States formulation
July 28, 2008 Approval Letter

Date: May 16, 2008
Package Insert Changes: Update the language in the package insert to be consistent with new content and format labeling requirements
May 16, 2008 Approval Letter

Date: September 12, 2007
New Formulation: 2007-2008 United States formulation
September 12, 2007 Approval Letter

Date: October 5, 2006
Indication: Active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
October 5, 2006 Approval Letter
FDA News: FDA Approves Additional Vaccine for Upcoming Influenza Season - 10/5/2006