| Product Information |
BR-1306_PI_01.pdf
|
| Registration Number |
BR-1306
|
| Generic Name |
Quadrivalent Seasonal Influenza Vaccine (Split Virion, Inactivated) 2025 Southern Hemisphere Strain
|
| Brand Name |
Vaxigrip Tetra
|
| 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/Croatia/10136RV/2023 (H3N2)-like strain
15 μg of HA**
(A/Croatia/10136RV/2023, X-425A)
B/Austria/1359417/2021 (B/Victoria lineage)-like virus
15 μg of HA**
(B/Michigan/01/2021, wild type)
B/Phuket/3073/2013 (B/Yamagata lineage)-like virus
με
15 μg of HA**
(B/Phuket/3073/2013, wild type)
*Propagated in fertilized hen's eggs from healthy chicken flocks
**Haemagglutinin
|
| Dosage Form |
Suspension for Injection (IM/SC)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
0.5 mL in 1 mL Type I pre-filled glass syringe with chlorobutyl plunger stopper and needle (Box of 1's)
|
| Pharmacologic Category |
Vaccines
|
| Manufacturer |
Sanofi Pasteur
|
| Country of Origin |
France
|
| Trader |
N/A
|
| Importer |
Sanofi Pasteur, Inc.
|
| Distributor |
Zuellig Pharma Corporation
|
| Application Type |
Monitored Release (Strain Clearance) (Re-application)
|
| Issuance Date |
21 April 2025
|
| Expiry Date |
21 April 2026
|