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July 4th, 2008
Press release - Octaplas® has been granted a renewal of the marketing authorization for 5 years
Octapharma is pleased to announce, with 4th of March 2008 as the official date, that the Health Authorities in Belgium, Finland, Ireland, Luxembourg, Netherlands, Sweden and the United Kingdom have renewed the Marketing Authorization of octaplas®.
octaplas® is a pharmaceutically licensed alternative to plasma for transfusion. Besides being solvent/detergent virus inactivated, the product is standardized in its protein content, which promotes a better planning and monitoring of treatment. Furthermore, the removal of all residual blood cells and neutralization of both allergens and antibodies against leukocytes render this medicinal product virtually free from causing allergic reactions and the risk for transfusion-related acute lung injuries (TRALI), being the most common cause of death in transfusion medicine, has been abolished.
octaplas® increases through these multiple favourable features the level of efficacy and security in transfusion medicine, both representing the foundation in all medical care, and reduce costs. The product is used to treat complex and isolated coagulation disorders both congenital and acquired where no specific coagulation factor concentrate is available, and Thrombotic Thrombocytopenic Purpura (TTP) usually in conjunction with plasma exchange. octaplas® is fully licensed in 29 countries worldwide, and roughly 6 million bags have been used successfully to treat approximately 2 million patients around the world since 1991. Nowadays countries like Norway, Finland and Portugal use octaplas® as the sole source of plasma for transfusion.
This product is not licensed in the USA.
© Octapharma AG, 2008
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