CLARISCAN

GE Healthcare🇺🇸 United States

FDA Page

Effective Date: Apr 30, 2026
Approval ID: c9e273b3-481f-4899-8913-95aaddcc7662
Products: 1 registered
Version: 12

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use CLARISCAN safely and effectively. See full prescribing information for CLARISCAN. CLARISCAN™ (gadoterate meglumine) injection for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013

Quick Stats

Total Products1

Labelers2

Label Sections21

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.