Vaccines, Blood & Biologics
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Agriflu
STN: BL 125297/32
Proper Name: Influenza Virus Vaccine
Tradename: Agriflu
Manufacturer: Novartis Vaccines and Diagnostics Inc., License #1751
Indication:
- 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
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Supporting Documents
October 24, 2012 Approval Letter - Agriflu
To include the 2012-2013 United States formulation.Summary Basis for Regulatory Action - Agriflu October 29, 2010 Approval Letter - Agriflu
to include data from the confirmatory clinical studies to verify and describe the clinical benefit.October 8, 2010 Approval Letter - Agriflu
Revised the Package Insert to include the appropriate warnings regarding natural rubber latexDear Health Care Provider Letter: Fluvirin and Agriflu (Influenza Virus Vaccine) Pre-Filled Syringes July 27, 2010 Approval Letter - Agriflu
New Formulation: 2010-2011 United States formulation.November 27, 2009 Approval Letter - Agriflu Approval History, Letters, Reviews, and Related Documents - Agriflu
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