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About MyozymeTM
MyozymeTM (alglucosidase alfa) has been approved by the EMEA in March 2006 and by the FDA in April 2006 for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Pompe disease. The product is the first treatment ever approved for Pompe disease and one of the first for an inherited muscle disorder. MyozymeTM is reimbursed in Belgium since the 1st of May 2007. Download Dutch RIZIV reimbursement form (PDF). Download French INAMI reimbursement form (PDF). MyozymeTM is the recombinant form of human α-glucosidase and is produced by recombinant DNA technology using Chinese Hamster Ovary (CHO) cell culture. It targets the underlying cause of the disease by replacing the deficient enzyme (α-glucosidase). The recommended dosage is 20 mg/kg of body weight administered once every two weeks by IV infusion. Please see the full prescribing information in Dutch or in French (PDF) for MyozymeTM. To access information about the steps required to reconstitute and administer Myozyme see Reconstitution and Administration. |
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