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Primary hypercholesterolaemia: Rosuvastatin/Ezetimibe is indicated as adjunct to diet for treatment of primary hypercholesterolaemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products.
Homozygous Familial Hypercholesterolemia (HoFH): Rosuvastatin/Ezetimibe is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).
Prevention of cardiovascular events: Rosuvastatin/Ezetimibe is indicated to reduce the risk of cardiovascular events as substitution therapy in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), who are adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products.
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