Vaccines, Blood & Biologics
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Fluvirin
STN: BL 103837
Proper Name: Influenza Virus Vaccine
Tradename: Fluvirin
Manufacturer: Novartis Vaccines and Diagnostics Limited, License #1750
Indication:
- For active immunization of persons 4 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
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Supporting Documents
July 20, 2012 Approval Letter - Fluvirin
To include the 2012-2013 United States formulation.May 3, 2012 Approval Letter - Fluvirin
Revised the Package Insert to clarify vaccine administration instructionsJune 30, 2011 Approval Letter - Fluvirin 2011/2012 Formulation
2011-2012 United States Formulation.August 24, 2010 Approval Letter - Fluvirin
Revised the Package Insert to include the appropriate warnings regarding natural rubber latex containing components in the tip caps of the pre-filled syringes.July 28, 2010 Approval Letter - Fluvirin
New Formulation: 2010-2011 United States formulationJuly 17, 2009 Approval Letter - Fluvirin
New Formulation: 2009/2010 Season FormulationAugust 1, 2008 Approval Letter - Fluvirin
New Formulation: 2008-2009 United States formulation.July 24, 2007 Approval Letter - Fluvirin
New Formulation: 2007-2008 United States formulation.July 21, 2006 Approval Letter - Fluvirin
New Formulation: 2006-2007 United States formulation.September 14, 2005 Approval Letter - Fluvirin
New Formulation: 2005-2006 United States formulation.
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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