EMA: First specific replacement therapy to treat rare bleeding disorder
29.01.2016
Coagadex recommended for approval for prevention of bleeding episodes for patients with factor X deficiency
The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Coagadex (human coagulation factor X) to treat factor X deficiency, a rare inherited bleeding disorder.
Coagadex is indicated for the treatment and preventive management of bleeding episodes and the control of bleeding during surgical procedures in patients with hereditary factor X deficiency. The medicine’s active substance is human coagulation factor X, a protein derived from human plasma.
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