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Vaccines, Blood & Biologics

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Fluarix Quadrivalent

STN: BL 125127
Proper Name: Influenza Virus Vaccine
Tradename: Fluarix Quadrivalent
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indication:

For active immunization of persons 3 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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Product Information

Package Insert - Fluarix Quadrivalent (PDF - 259KB)

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Supporting Documents

December 14, 2012 Approval Letter- Fluarix Quadrivalent
To include a quadrivalent influenza virus vaccine formulation for use in persons 3 years of age and older.
November 30, 2012 - Summary Basis of Regulatory Action -Fluarix Quadrivalent (PDF - 358KB)
Statistical Review and Evaluation - Fluarix® Quadrivalent (PDF - 2.4MB)
Clinical Review - Fluarix Quadrivalent (PDF - 817KB)

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