KEPIVANCE

Swedish Orphan Biovitrum AB (publ)🇺🇸 United States

FDA Page

Effective Date: Aug 1, 2023
Approval ID: 426f6e64-2c20-4a61-6d65-7320426f6e64
Products: 2 registered
Version: 19

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use Kepivance safely and effectively. See full prescribing information for KEPIVANCE. KEPIVANCE (palifermin) for injection, for intravenous use Initial U.S. Approval: 2004

Quick Stats

Total Products2

Labelers2

Label Sections16

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.