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In this section: Vaccines

FluMist Quadrivalent

STN: 125020
Proper Name: Influenza Vaccine
Tradename: FluMist Quadrivalent
Manufacturer: MedImmune, LLC
Indications:

For active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluMist Quadrivalent is approved for use in persons 2 through 49 years of age

Product Information

Package Insert - FluMist Quadrivalent

Supporting Documents

June 30, 2023 Approval Letter - FluMist Quadrivalent
January 12, 2023 Approval Letter - FluMist
July 27, 2022 Approval Letter - FluMist Quadrivalent
July 20, 2021 Approval Letter - FluMist
July 9, 2020 Approval Letter - FluMist
April 14, 2020 Approval Letter - FluMist
July 15, 2019 Approval Letter - FluMist
February 28, 2019 Approval Letter - FluMist Quadrivalent
To remove information from the Use in Specific Populations section of the Highlights of Prescribing Information of the package insert (PI) for clarity.
August 10, 2018 Approval Letter - FluMist Quadrivalent
To include the 2018-2019 United States formulation and associated labeling revisions.
May 15, 2018 Approval Letter - FluMist Quadrivalent
To revise package insert to comply with Pregnancy and Lactation Labeling Rule.
March 17, 2017 Approval Letter - FluMist Quadrivalent
To revise the Ovalbumin test release specification and make the associated changes to the labeling.
Supporting Documents older than three years - FluMist Quadrivalent

Related Information

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