Product Approval Information
Proper Name: Immune Globulin Subcutaneous (Human)
Tradename: Vivaglobin
Manufacturer: CSL Behring GmbH, License #1765
Package Insert (PDF - 152 KB) - Approved: January 9, 2006
Date: January 9, 2006
Indication: Treatment of patients with primary immune deficiency (PID)
January 9, 2006 Approval Letter
FDA Approves First Immune Globulin for Subcutaneous Use - January 9, 2006
Summary Basis of Approval (PDF-186 KB) - January, 2006