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Product Information BR-1084_PI_01.pdf
Registration Number BR-1084
Generic Name Quadrivalent Seasonal Influenza Vaccine (Split) Virion, Inactivated) 2024 Southern Hemisphere Strain.
Brand Name Fluquadri
Dosage Strength Formulation: Each dose (0.5 mL) contains the following influenza strains*: A/Victoria/4897/2022 (H1N1) pdm09-like strain 15 μg of HA** (A/Victoria/4897/2022, IVR-238) A/Thailand/8/2022 (H3N2)-like strain 15 μg of HA** (A/California/122/2022, SAN-022) B/Austria/1359417/2021-like strain 15 μg of HA** (B/Michigan/01/2021, wild type) B/Phuket/3073/2013 (B/Yamagata lineage)-like virus 15 μg of HA** (B/Phuket/3073/2013, wild type) *Propagated in embryonated chicken eggs
Dosage Form Suspension for Injection (IM)
Classification Prescription Drug (Rx)
Packaging 0.5 mL in 1.5 mL USP Type I borosilicate pre-filled glass syringe with bromobutyl plunger stopper, luer- lock adapter, and tip cap (Box of 5's).
Pharmacologic Category Vaccines
Manufacturer Sanofi Pasteur
Country of Origin U.S.A
Trader
Importer Sanofi Pasteur, Inc.
Distributor Zuellig Pharma Corporation
Application Type Monitored Release (Strain Clearance)
Issuance Date 05 April 2024
Expiry Date 05 April 2025