Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 16 May 2017


Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.

Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well-tolerated.

Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia.

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Category Value
Agency product number EMEA/H/C/000512
Orphan designation No
Date First Approved 10-03-2004
Type Medicinal product subject to medical prescription
Marketing authorisation holder Genzyme Europe B.V.