Vaccines, Blood & Biologics
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Fluarix
STN: BL 125127
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
July 20, 2012 Approval Letter - Fluarix
To include the 2012-2013 United States formulation.July 16, 2012 Approval Letter - Fluarix
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 - Fluarix
To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.June 30, 2011 Approval Letter -Fluarix 2011/2012 Forumation
2011-2012 United States FormulationClinical Review - Fluarix
Persons 3 years of age and olderDear Health Care Provider Letter: Information Re Fluarix® (Influenza Virus Vaccine): Tip Caps Of The Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions in Latex Sensitive Individuals July 29, 2010 Approval Letter - Fluarix
New Formulation: 2010-2011 United States formulation.July 19, 2010 Approval Letter - Fluarix
Fulfilled the pediatric study requirement for all relevant pediatric age groups for this application.April 23, 2010 Approval Letter - Fluarix
Revised Package Insert and carton to remove precautions for latex-containing components.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 benefitJuly 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.BLA Clinical Review - Fluarix (PDF - 4.8MB)Statistical Review - Fluarix (PDF - 277KB)Statistical Review and Evaluation - Fluarix
BLA supplement seeking indication for active immunization of person 3 years of age and older.
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