# FLUARIX 2026/2027 (influenza virus vaccine) by GlaxoSmithKline Biologicals SA: new vaccine listing

**Launch Signal Score:** 70/100

| Field | Value |
|---|---|
| Product | FLUARIX 2026/2027 |
| Generic name | influenza virus vaccine |
| NDC | 58160-725 |
| Labeler | GlaxoSmithKline Biologicals SA |
| Product type | VACCINE |
| Approval pathway | BLA |
| Application number | BLA125127 |
| Dosage form | SUSPENSION |
| Route | INTRAMUSCULAR |
| Active ingredients | INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL; INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL |
| Marketing start | 2026-07-01 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=58160-725). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.