BKEMV

🇺🇸 United States

FDA Page

Effective Date: Jul 2, 2026
Approval ID: 002f9748-b0e8-4b6e-a38b-56930a839491
Products: 0 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BKEMV safely and effectively. See full prescribing information for BKEMV. BKEMV (eculizumab-aeeb) injection, for intravenous use Initial U.S. Approval: 2024 BKEMV (eculizumab-aeeb) is biosimilar to SOLIRIS (eculizumab).

Quick Stats

Total Products0

Labelers0

Label Sections0

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.