FLUCELVAX

STN: 125408
Proper Name: Influenza Vaccine
Tradename: FLUCELVAX
Manufacturer: Seqirus, Inc.
Indication:

• Flucelvax is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
• Flucelvax is approved for use in persons 6 months of age and older.

Product Information

• Package Insert - FLUCELVAX

Supporting Document

• March 23, 2026 Approval Letter - FLUCELVAX
• July 1, 2025 Approval Letter - FLUCELVAX
• July 1, 2024 Approval Letter - FLUCELVAX
• May 2, 2016 Clinical Review Addendum - FLUCELVAX
• Statistical Review (STN: 125408/101) - FLUCELVAX
• Approval History, Letters, Reviews, and Related Documents - Flucelvax
• Supporting documents older than 3 years - Flucelvax