Fluzone, Fluzone High-Dose and Fluzone Intradermal
STN: BL 103914
Proper Name: Influenza Virus Vaccine
Tradename: Fluzone, Fluzone High-Dose and Fluzone Intradermal
Manufacturer: Sanofi Pasteur, Inc (for Fluzone High-Dose and Fluzone Intradermal only)
Indication:
- Fluzone is indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
- Fluzone High-Dose is indicated for active immunization of persons 65 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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Fluzone Intradermal indicated for active immunization for use in adults 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
Product Information
Supporting Documents
- July 2, 2019 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose
- January 23, 2019 Approval Letter - Fluzone High-Dose
- June 29, 2018 Approval Letter- Fluzone
- January 10, 2018 Approval Letter - Fluzone
- July 7, 2017 Approval Letter - Fluzone
- Clinical Review Memorandum - Fluzone High-Dose Quadrivalent
- Toxicology Review - Fluzone High-Dose Quadrivalent
- Statistical Review -Fluzone High-Dose
- Supporting Documents older than three years - Fluzone, Fluzone High-Dose and Fluzone Intradermal