Arepanrix

GlaxoSmithKline Biologicals SA🇺🇸 United States

FDA Page

Effective Date: Apr 28, 2026
Approval ID: ecf36ac9-9eb7-4008-8657-9bb6fb1bb28c
Products: 1 registered
Version: 1

Regulatory Information

Labeling Type

VACCINE LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use AREPANRIX safely and effectively. See full prescribing information for AREPANRIX. AREPANRIX (Influenza A [H5] Monovalent Vaccine, Adjuvanted) injectable emulsion, for intramuscular useInitial U.S. Approval: 2013

Quick Stats

Total Products1

Labelers1

Label Sections16

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.