Following a full submission
AWMSG advice |
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Status: Recommended | ||
Agalsidase alfa (Replagal®) should be recommended for use within NHS Wales as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. Patients receiving agalsidase alfa (Replagal®) will be entered into the Fabry Outcomes Survey. AWMSG urge the manufacturers of agalsidase alfa and agalsidase beta to develop a combined outcomes database. Treatment will be administered under the supervision of a physician experienced in the management of Fabry disease or other inherited metabolic diseases. Treatment will be administered according to agreed guidelines at appropriate designated centres. AWMSG will review this and other enzyme replacement therapies within three years. |
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Medicine details |
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Medicine name | agalsidase alfa (Replagal®) | |
Formulation | 1 mg/ml concentrate for solution for infusion | |
Reference number | 11 | |
Indication | Long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency) |
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Company | Shire Human Genetic Therapies | |
BNF chapter | Nutrition & blood | |
Assessment type | Full | |
Status | Recommended | |
Advice number | 1107 | |
NMG meeting date | 12/09/2007 | |
AWMSG meeting date | 18/10/2007 | |
Ratification by Welsh Government | 15/11/2007 | |
Date of issue | 20/11/2007 |