| Product Information |
BR-1125_PI_01.pdf
|
| Registration Number |
BR-1125
|
| Generic Name |
Quadrivalent Seasonal Influenza Vaccine (Split Virion,
Inactivated) Southern Hemisphere 2024 Strain.
|
| Brand Name |
Fluarix Tetra
|
| Dosage Strength |
Each dose (0.5 mL) contains the following influenza strains*:
A/Victoria/4897/2022 (H1N1)pdm09-like strain
(A/Victoria/4897/2022, IVR-238)
A/Thailand/8/2022 (H3N2)-like strain
(A/Thailand/8/2022, IVR-237)
B/Austria/1359417/2021-like strain
(B/Austria/1359417/2021, BVR-26)
B/Phuket/3073/2013-like strain
(B/Phuket/3073/2013, wild type) [Yamagata lineage] *Propagated in embryonated chicken eggs
**Haemagglutinin
15 μg of HA**
15 μg of HA**
15 μg of HA**
15 μg of HA**
|
| Dosage Form |
Suspension for Injection (IM)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
0.5 mL in 1 mL Type I pre-filled glass syringe with luer lock adapter and plastic rigid tip cap (PRTC) and 2 separate needles (25G 5/8" and 25G 1") in a plastic tray (Box of 1's).
|
| Pharmacologic Category |
Vaccines
|
| Manufacturer |
GlaxoSmithKline Biologicals NL Der SmithKline
|
| Country of Origin |
Germany
|
| Trader |
|
| Importer |
GlaxoSmithKline Philippines, Inc.
|
| Distributor |
GlaxoSmithKline Philippines, Inc.
|
| Application Type |
Monitored Release (Strain Clearance)
|
| Issuance Date |
19 February 2024
|
| Expiry Date |
19 February 2025
|