Following non-submission
AWMSG advice |
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Status: Not endorsed (Statement of Advice) | ||
In the absence of a submission from the holder of the marketing authorisation, lomitapide (Lojuxta®) cannot be endorsed for use within NHS Wales in adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded. |
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Medicine details |
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Medicine name | lomitapide (Lojuxta®) | |
Formulation | 5 mg, 10 mg and 20 mg capsule | |
Reference number | 1182 | |
Indication | In adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded |
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Company | Aegerion Pharmaceuticals Ltd | |
BNF chapter | Cardiovascular system | |
Submission type | Non-submission | |
Status | Not endorsed (Statement of Advice) | |
Date of issue | 06/12/2013 |