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 a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.
• Fluzone High-Dose is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.

Product Information

• Package Insert - Fluzone
• Package Insert - Fluzone High-Dose
• Package Insert - Fluzone Intradermal

Supporting Documents

• July 1, 2024 Approval Letter- Fluzone and Fluzone High-Dose
• 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

Related Information

• Fluzone Vaccine Safety - ARCHIVED