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FDA Approves U.S. Market Return for octagam® Following Octapharma's Implementation of Enhanced Safety Measures
Date:11/4/2011

n other IVIG products, these were shown not to have contributed to the TEEs seen in association with octagam® 5%. Octapharma now utilizes a commercial absorbent early in the manufacturing process of octagam® 5% that minimizes the presence of Factor XI.

Earlier this year, multiple international regulatory agencies authorized the market return of octagam® 5% and octagam® 10% in worldwide markets. The product is presently approved for distribution in the U.S., Austria, Belgium, Bulgaria, Bosnia, Cyprus, Germany, Denmark, Estonia, Spain, Finland, France, Hungary, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia, Switzerland and the United Kingdom.

About octagam® 5%

Immune Globulin Intravenous (Human), octagam® 5% liquid, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. octagam® 5% liquid is a solution for infusion which must be administered intravenously.

octagam® is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich
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