Ultomiris

Alexion Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 28, 2024
Approval ID: a9a590d9-0217-43c7-908d-e62a71279791
Products: 4 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 ULTOMIRIS safely and effectively. See full prescribing information for ULTOMIRIS. ULTOMIRIS (ravulizumab-cwvz) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2018

Quick Stats

Total Products4

Labelers2

Label Sections42

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.