REBINYN

Novo Nordisk🇺🇸 United States

FDA Page

Effective Date: Aug 11, 2022
Approval ID: 0ea37235-35fd-410d-b8c4-40ba15fe1294
Products: 4 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use REBINYN safely and effectively. See full prescribing information for REBINYN.REBINYN (Coagulation Factor IX (Recombinant), GlycoPEGylated)lyophilized powder for solution for intravenous injectionInitial U.S. Approval: 2017

Quick Stats

Total Products4

Labelers2

Label Sections19

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.