Product Information

• Package Insert - AFLURIA (PDF - 1.5MB)

Supporting Documents

• April 4, 2013 Approval Letter - AFLURIA
  To revise the package insert.
• July 20, 2012 Approval Letter - Afluria
  To include the 2012-2013 United States formulation.
• December 2, 2011 Approval Letter - Afluria
  To include data from confirmatory clinical studies to verify and describe the clinical benefit and to include additional data describing use in children.
• Summary Basis for Regulatory Action, December 1, 2011 - Afluria (PDF - 160KB)
• August 30, 2010 Clarification Letter - Afluria
  This letter is to clarify your pediatric study fulfillment requirements.
• July 30, 2010 Approval Letter, Afluria
  2010-2011 United States formulation
• July 15, 2011 Approval Letter- AFLURIA 2011/2012 Formulation
  2011 -2012 United States Formulation
• November 10, 2009 Approval Letter - Afluria/Influenza A (H1N1) 2009 Monovalent
  Active immunization against influenza for individuals 6 months through 17 of age
• July 10, 2009 Approval Letter - Afluria 2009/2010 Season Formulation
• July 30, 2008 Approval Letter - Afluria
  2008-2009 United States formulation.
• September 28, 2007 - Afluria
  For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
• Additional Influenza Vaccine Approved for Upcoming Influenza Season [ARCHIVED]
  Press Release: September 29, 2007
• Approval History, Letters, Reviews, and Related Documents - AFLURIA

Related Information

• FDA Online Label Repository
  Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
• FDA Expands Use of CSL Limited’s Seasonal and H1N1 Vaccines to Infants and Children [ARCHIVED]
  Press Release: November 12, 2009

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