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Vaccines, Blood & Biologics
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Resources for You
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Fluarix
Proper Name: Influenza Virus Vaccine
Tradename: Fluarix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indication:
- For active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information for Fluarix®.
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Supporting Documents
- October 19, 2009 Approval Letter - Fluarix
Indication: For active immunization against influenza for individuals 3 years of age or older. - October 2, 2009 Approval Letter - Fluarix
To include data from the confirmatory clinical studies to verify and describe the clinical benefit - July 15, 2009 Approval Letter - Fluarix
New Formulation: 2009-2010 Season Formulation. - April 1, 2009 Approval Letter - Fluarix
Revised Formulation: To include a thimerosal-free formulation in single-dose prefilled syringes and related changes in the labeling. - August 5, 2008 Approval Letter - Fluarix
New Formulation: 2008-2009 United States formulation. - July 24, 2007 Approval Letter - Fluarix
New Formulation: 2007-2008 United States formulation. - July 25, 2006 Approval Letter - Fluarix
New Formulation: 2006-2007 United States formulation. - August 31, 2005 Approval Letter - Fluarix
Indication: For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B. - Clinical Review - Fluarix (PDF - 4215KB)
- Statistical Review - Fluarix (PDF - 277KB)
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