Mircera

Vifor (International) Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 14, 2026
Approval ID: 22c56f2a-f73c-60e7-e054-00144ff88e88
Products: 9 registered
Version: 10

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use MIRCERA safely and effectively. See full prescribing information for MIRCERA. MIRCERA (methoxy polyethylene glycol-epoetin beta) injection, for intravenous or subcutaneous useInitial U.S. Approval: 2007

Quick Stats

Total Products9

Labelers2

Label Sections27

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.