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Vaccines, Blood & Biologics

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Immune Globulin

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Immune Globulin Intravenous (IGIV) Indications

List is in Order by Manufacturer

Product	Manufacturer	Indications
Gammagard Liquid	Baxter Healthcare Corporation	Treatment of primary immunodeficiency disorders associated with defects in humoral immunity
Gammagard S/D	Baxter Healthcare Corporation	Prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia. Prevention of coronary artery aneurysms associated with Kawasaki Syndrome. To induce rapid rise in platelet count when needed to prevent and/or to control bleeding in a patient with Idiopathic Thrombocytopenic Purpura.
Iveegam E/N	Baxter Healthcare Corporation	Replacement therapy in patients with primary immunodeficiency syndromes (PIDD) Kawasaki syndrome
Polygam S/D	Baxter Healthcare Corporation	Primary Humoral Immunodeficiency Immune Mediated Thrombocytopenia
Carimune NF	CSL Behring AG	Primary Humoral Immunodeficiency Immune Thrombocytopenic Purpura
Gammar-P I.V.	CSL Behring AG	Primary Humoral Immunodeficiency
Panglobulin NF	CSL Behring AG	Primary Humoral Immunodeficiency Immune Thrombocytopenic Purpura
Privigen	CSL Behring AG	Primary Immunodeficiency Chronic Immune Thrombocytopenic Purpura
Flebogamma DIF 5%	Grifols	Replacement therapy in primary (inherited) humoral immune deficiency disorders
Venoglobulin-S	Grifols Biologicals, Inc.	Primary Humoral Immunodeficiency Immune Mediated Thrombocytopenia Kawasaki syndrome
Octagam	Octapharma	Treatment of Primary Humoral Immunodeficiency
Gamimune N	Talecris Biotherapeutics, Inc.	Primary Humoral Immunodeficiency Immune Mediated Thrombocytopenia Bone marrow transplantation Pediatric HIV-1
Gamunex	Talecris Biotherapeutics, Inc	Primary Humoral Immunodeficiency Idiopathic Thrombocytopenic Purpura Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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Food and Drug Administration

1401 Rockville Pike

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Rockville, MD 20852-1448

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