STN: BL 125297/32
Proper Name: Influenza Virus Vaccine
Manufacturer: Novartis Vaccines and Diagnostics Inc.
- 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
Package Insert - AGRIFLU(PDF - 156KB) [ARCHIVED]
October 21, 2013 Approval Letter - Agriflu[ARCHIVED]
To include a multi-dose vial (MDV) presentation for marketing beginning with the 2014-2015 influenza season at which time relevant labeling will need to be submitted with your strain change supplement.
October 24, 2012 Approval Letter - Agriflu[ARCHIVED]
To include the 2012-2013 United States formulation.
Summary Basis for Regulatory Action - Agriflu[ARCHIVED] October 29, 2010 Approval Letter - Agriflu[ARCHIVED]
to include data from the confirmatory clinical studies to verify and describe the clinical benefit.
October 8, 2010 Approval Letter - Agriflu[ARCHIVED]
Revised the Package Insert to include the appropriate warnings regarding natural rubber latex
Dear Health Care Provider Letter: Fluvirin and Agriflu (Influenza Virus Vaccine) Pre-Filled Syringes[ARCHIVED] July 27, 2010 Approval Letter - Agriflu[ARCHIVED]
New Formulation: 2010-2011 United States formulation.
November 27, 2009 Approval Letter - Agriflu[ARCHIVED] Approval History, Letters, Reviews, and Related Documents - Agriflu[ARCHIVED]