Australia - English - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; povidone - adults (greater than or equal to 18 years) primary hypercholesterolaemia: - zient administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia. homozygous familial hypercholesterolaemia (hofh): - zient, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis). homozygous sitosterolaemia (phytosterolaemia): - zient is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,,prevention of cardiovascular disease zient is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche) heterozygous familial hypercholesterolaemia (hefh): - zient co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:- patients not appropriately controlled with a statin or ezetimibe alone; - patients already treated with a statin and ezetimibe homozygous familial hypercholesterolaemia (hofh): -zient co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

Canada - English - Health Canada

sivem pharmaceuticals ulc - ezetimibe - tablet - 10mg - ezetimibe 10mg - cholesterol absorption inhibitors

Canada - English - Health Canada

sanis health inc - ezetimibe - tablet - 10mg - ezetimibe 10mg - cholesterol absorption inhibitors

Canada - English - Health Canada

mantra pharma inc - ezetimibe - tablet - 10mg - ezetimibe 10mg - cholesterol absorption inhibitors

United States - English - NLM (National Library of Medicine)

par pharmaceutical inc - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. monotherapy ezetimibe, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. combination therapy with hmg-coa reductase inhibitors (statins) ezetimibe, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-c, ld

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - ezetimibe - oral tablet - 10mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - ezetimibe - oral tablet - 10mg

Canada - English - Health Canada

laboratoire riva inc. - ezetimibe - tablet - 10mg - ezetimibe 10mg - cholesterol absorption inhibitors

Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - ezetimibe; simvastatin - tablet - 10 mg/40 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - ezetimibe; simvastatin - tablet - 10 mg/80 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe