| Product Information |
BR-1421_PI_01.pdf
|
| Registration Number |
BR-1421
|
| Generic Name |
Quadrivalent Seasonal Influenza Vaccine (Split Virion, Inactivated) 2024 Southern Hemisphere Strain.
|
| Brand Name |
Fluquadri
|
| Dosage Strength |
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
**Haemagglutinin
|
| Dosage Form |
Suspension for Injection (IM)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Vaccines
|
| Packaging |
Multidose (10 doses). 5 mL USP Type I glass vial
with gray chlorobutyl stopper and aluminum flip seal cap (Box of 1's).
|
| Manufacturer |
Sanofi Pasteur
|
| Country of Origin |
U.S.A
|
| Trader |
|
| Importer |
Sanofi Pasteur, Inc.
|
| Distributor |
Sanofi Pasteur, Inc.
|
| Application Type |
Monitored Release (Strain Clearance)
|
| Issuance Date |
27 March 2024
|
| Expiry Date |
27 March 2025
|