Basic Information
Fluzone QIV SH 2025
49281-357
Regulatory Information
49281-357
BLA103914
C73585
March 21, 2025
USA
These highlights do not include all the information needed to use Fluzone Quadrivalent Southern Hemisphere safely and effectively. See full prescribing information for Fluzone Quadrivalent Southern Hemisphere. Fluzone Quadrivalent (Influenza Vaccine) injectable suspension, for intramuscular use 2025 Formula Initial U.S. Approval: 2013
VACCINE LABEL
16
Company Information
086723285
Active Ingredients
THIMEROSAL
Code: 2225PI3MOV
Class Code: IACT
OCTOXYNOL-9
Code: 7JPC6Y25QS
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
SODIUM CHLORIDE
Code: 451W47IQ8X
Class Code: IACT
Quantity: 15 ug in 0.5 mL
Code: AU5C98U4BB
Class Code: ACTIM
Quantity: 15 ug in 0.5 mL
Code: B93BQX9789
Class Code: ACTIM
Quantity: 15 ug in 0.5 mL
Code: FF9YP4D23C
Class Code: ACTIM
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
Code: KH7I04HPUU
Class Code: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Code: 22ADO53M6F
Class Code: IACT
FORMALDEHYDE
Code: 1HG84L3525
Class Code: IACT
Quantity: 15 ug in 0.5 mL
Code: HQW9FZS4YK
Class Code: ACTIM
Active Moieties
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
Code: SD82XNG5M6
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
Code: C46XJT9FQ9
INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
Code: 9HB0XUS9TM
INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
Code: CQV855H5FG