Product Approval Information
Proper Name: Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified
Tradename: Gamunex
Manufacturer: Talecris Biotherapeutics, Inc, License #1716
Package Insert (PDF - 81 KB) - Approved: August 27, 2003
Date: August 27, 2003
Indication: Primary humoral immunodeficiency and idiopathic thrombocytopenic purpura
August 27, 2003 Approval Letter