Unistat : Influenza Virus Vaccine
Influenza, also known as the flu, is a contagious disease that is caused by influenza viruses. Influenza viruses infect the respiratory tract (nose, throat, and lungs) in humans. The flu is different from a cold, mainly because the symptoms and complications are more severe. Influenza usually comes on suddenly and may include these symptoms: fever, headache, malaise (a feeling of being ill and without energy that can be extreme), cough, sore throat, nasal congestion and body aches.
Influenza Virus Vaccine
Proper name: Influenza
Virus Vaccine
Tradename: Fluarix
Manufacturer: GlaxoSmithKline Biologics, Rixensart
Belgium, License #1617
New Formulation: 2006-2007 United States formulation
Approval Date: 7/25/2006
Type of submission: Biologics license application
supplement
STN: 125127 / 139
Proper name: Influenza
Virus Vaccine
Tradename: Fluarix
Manufacturer: GlaxoSmithKline Biologics, Rixensart
Belgium, License #1617
Indication for use: For active immunization of
adults 18 years of age and older against influenza disease
caused by influenza virus types A and B
Approval Date: 8/31/2005
Type of submission: Biologics license application
STN: 125127 / 0
Proper name: Influenza
Virus Vaccine
Tradename: FluLaval
Manufacturer: ID Biomedical Corporation of Quebec,
Quebec City, QC, Canada, License #1739
Indication for Use: Active immunization of adults 18
years of age and older against influenza disease caused by
influenza virus subtypes A and type B contained in the
vaccine
Approval Date: 10/5/2006
Type of submission: Biologics license application
STN: 125163 / 0
Proper name: Influenza
Virus Vaccine
Tradename: Fluvirin
Manufacturer: Chiron Vaccines Ltd, Liverpool
UK, License #1720
Labeling revisions and 2006-2007 United States formulation
Approval Date: 7/21/2006
Type of submission: Biologics license application
supplement
STN: 103837 / 5104
Proper name: Influenza
Virus Vaccine
Tradename: Fluvirin
Manufacturer: Chiron Vaccines Ltd, Liverpool
UK, License #1720
New Formulation: 2005-2006 United States formulation
Approval Date: 9/14/2005
Type of submission: Biologics license application
supplement
STN: 103837 / 5066
Proper name: Influenza
Virus Vaccine
Tradename: Fluzone
Manufacturer: Sanofi Pasteur Inc., Swiftwater,
PA, License #1725
New Formulation: 2006-2007 United States formulation
Approval Date: 7/10/2006
Type of submission: Biologics license application
supplement
STN: 103914 / 5125
Proper name: Influenza
Virus Vaccine
Tradename: Fluzone
Manufacturer: Aventis Pasteur Inc, Swiftwater,
PA, License #1277
New Formulation: 2005-2006 United States formulation
Approval Date: 7/14/2005
Type of submission: Biologics license application
supplement
STN: 103914 / 5097
Proper name: Influenza
Virus Vaccine
Tradename: Fluzone
Manufacturer: Aventis Pasteur Inc, Swiftwater,
PA, License #1277
New Formulation: Preservative free single dose
presentation in a unit dose vial
Approval Date: 7/14/2005
Type of submission: Biologics license application
supplement
Proper name: Influenza
Virus Vaccine
Tradename: Fluzone
Manufacturer: Aventis Pasteur Inc, Swiftwater,
PA, License #1277
New Formulation: Single dose formulation without
thimerosal for the 0.25 mL and 0.5 mL syringes
Approval Date: 12/23/2004
Type of submission: Biologics license application
supplement
Proper name: Influenza
Virus Vaccine
Tradename: Fluzone
Manufacturer: Aventis Pasteur Inc, Swiftwater,
PA, License #1277
New Formulation: Preservative free formulation in a
single dose presentation in 0.25 ml syringes for pediatric
use and 0.5 ml syringes for adults and children
Approval Date: 9/4/2002
Type of submission: Biologics license application
supplement
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