The Committee for Medicinal Products for Human Use (CHMP) concluded that Cholestagel’ s benefits are greater than its risks as adjunctive therapy to diet to provide additive reduction in LDL cholesterol levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone, and as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL- cholesterol in adult patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.