Arexvy

GlaxoSmithKline Biologicals SA🇺🇸 United States

FDA Page

Effective Date: Jul 27, 2026
Approval ID: 1e50f275-002e-413f-a840-66ee3cb3740c
Products: 1 registered
Version: 13

Regulatory Information

Labeling Type

VACCINE LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use AREXVY safely and effectively. See full prescribing information for AREXVY. AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) for injectable suspension, for intramuscular useInitial U.S. Approval: 2023

Quick Stats

Total Products1

Labelers1

Label Sections15

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.