Proper Name: Immune Globulin Intravenous (Human)
Tradename: Flebogamma DIF 10%
Manufacturer: Instituto Grifols, SA, License #1181
Indication: For the treatment of primary immune deficiency (PI) including the humoral immune defect in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome.
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September 23, 2013 Approval Letter - FLEBOGAMMA 10% DIF[ARCHIVED]
Approval Letter for Safety Labeling Changes
July 27, 2010 Approval Letter - Flebogamma DIF 10%[ARCHIVED] Summary Basis for Regulatory Action - Flebogamma DIF 10%(PDF - 452KB)