QUILOGA (rosuvastatin/ezetimibe) - Hypercholesterolaemia

Summary of opinion

Favourable opinion for reimbursement of QUILOGA (rosuvastatin/ezetimibe) in the MA indication: “Primary hypercholesterolaemia/homozygous familial hypercholesterolaemia (HoFH)

QUILOGA is indicated as an adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and nonfamilial) or homozygous familial hypercholesterolaemia as substitution therapy in adult patients, adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination medicinal product, but as separate products.”

No clinical added value compared to the free combination of rosuvastatin and ezetimibe given concurrently at the same dosage.