Proper Name: Influenza Vaccine
Manufacturer: Seqirus, Inc.
For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
- August 31, 2016 Approval Letter - Flucelvax
To include the use of MDCK cell isolated candidate vaccine virus strains obtained from two supporting WHO Collaborating Centers for the manufacture of monovalent bulks.
- May 23, 2016 Summary Basis of Regulatory Action - Flucelvax
- May 23, 2016 Approval Letter - Flucelvax
To include persons 4 years to <18 years of age according to the regulations for accelerated approval, 21 CFR 601.40-46.
- May 2, 2016 Clinical Review Addendum - FLUCELVAX
- Statistical Review (STN: 125408/101) - FLUCELVAX
- July 2, 2015 Approval Letter - Flucelvax
To Include the 2015 - 2016 United States formulation and corresponding labeling.
- April 2, 2015 Approval Letter - Flucelvax
To include changes to the package insert.
- Approval History, Letters, Reviews, and Related Documents - Flucelvax
- Supporting documents older than 3 years - Flucelvax