ILLUCCIX

Telix Pharmaceuticals (US) Inc.🇺🇸 United States

FDA Page

Effective Date: Jun 15, 2026
Approval ID: d4643b31-9b4f-673f-e053-2a95a90a559d
Products: 1 registered
Version: 16

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ILLUCCIX safely and effectively. See full prescribing information for ILLUCCIX. ILLUCCIX® (kit for the preparation of gallium Ga 68 gozetotide injection), for intravenous use Initial U.S. Approval: 2020

Quick Stats

Total Products1

Labelers2

Label Sections35

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.