Vaccines, Blood & Biologics
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FluLaval
STN: BL 125163
Proper Name: Influenza Virus Vaccine
Tradename: FluLaval
Manufacturer: ID Biomedical Corporation of Quebec, License #1739
Indications:
- 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
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Supporting Documents
July 20, 2012 Approval Letter - FluLaval
To include the 2012-2013 United States formulation.July 16, 2012 Approval Letter - FluLaval
Updated information regarding instruction on the method of vaccine administration to the Dosage and Administration section of the package insert.March 12, 2012 Approval Letter - FluLaval
To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.December 14, 2011 Approval Letter - FluLaval
To manufacture ------------(b)(4)---------------------------------------------- and for a new thimerosal-containing formulation for presentation in multi-dose vials.June 30, 2011 Approval Letter - FluLaval 2011/2012 Forumation
2011-2012 United States FormulationSummary Basis for Regulatory Action - FluLaval June 9, 2011 Approval Letter - FluLaval
To include data from a clinical endpoint study and a non-inferiority immunogenicity study conducted in adults in the prescribing information.July 23, 2010 Approval Letter - FluLaval
2010/2011 United States FormulationApril 23, 2010 Approval Letter - FluLaval
Revised: The Pregnancy Category in the package insert from the current Pregnancy Category C to Pregnancy Category B.July 10, 2009 Approval Letter - FluLaval
New Formulation: 2009/2010 Season FormulationJuly 28, 2008 Approval Letter - FluLaval
New Formulation: 2008-2009 United States formulation.May 16, 2008 Approval Letter - FluLaval
Package Insert Changes: Update the language in the package insert to be consistent with new content and format labeling requirements.September 12, 2007 Approval Letter - FluLaval
New Formulation: 2007-2008 United States formulation.October 5, 2006 Approval Letter - FluLaval
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.
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Related Information
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