Ryplazim

Kedrion Biopharma, Inc.🇺🇸 United States

FDA Page

Effective Date: Sep 15, 2025
Approval ID: 5c5a00ca-d662-46e6-b9ac-a07e9cfcc0a8
Products: 1 registered
Version: 8

Regulatory Information

Labeling Type

PLASMA DERIVATIVE

Status

Approved

Full Title

These highlights do not include all the information needed to use RYPLAZIM safely and effectively. See full prescribing information for RYPLAZIM. RYPLAZIM (plasminogen, human-tvmh) lyophilized powder for reconstitution, for intravenous use Initial U.S. Approval: 2021

Quick Stats

Total Products1

Labelers1

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.