États-Unis - anglais - NLM (National Library of Medicine)

major pharmaceuticals - 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 to

États-Unis - anglais - NLM (National Library of Medicine)

ascend laboratories, llc - 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 tablets, 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 tablets, 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 elev

Philippines - anglais - FDA (Food And Drug Administration)

n/a; importer: stada philippines inc; distributor: stada philippines inc - simvastatin , ezetimibe - tablet - 80 mg/ 10 mg

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - ezetimibe 10mg;   - tablet - 10 mg - active: ezetimibe 10mg   excipient: croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate - ezetimibe sandoz administered with an hmg-coa reductase inhibitor (statin) or 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 triglycerides (tg) and to increase high-density lipoprotein cholesterol (hdl-c) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: hypromellose; lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose - adults (? 18 years),primary hypercholesterolaemia,ezetimibe 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),ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),ezetimibe, is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,ezetimibe, 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 risk of cardiovascular events following at least one year therapy (see section 5.1 pharmacodynamic properties, 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),ezetimibe 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),ezetimibe 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)

Israël - anglais - Ministry of Health

novartis israel ltd - ezetimibe - tablets - ezetimibe 10 mg - ezetimibe - primary hypercholesterolemia: ezetimibe sandoz administered with an hmg-coa reductase inhibitor (statin) or alone are indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. homozygous familial hypercholesterolemia (hofh): ezetimibe sandoz administered with a statin are indicated for use in patients with hofh.patients may also receive adjunctive treatments (e.g. ldl apheresis).homozygous sitosterolemia (phytosterolemia): ezetimibe sandoz are indicated for use in patients with homozygous familial sitosterolemia.

Israël - anglais - Ministry of Health

abic marketing ltd, israel - ezetimibe - tablets - ezetimibe 10 mg - ezetimibe - - primary hypercholesterolemia: ezetimibe teva administered with an hmg-coa reductase inhibitor (statin) or alone are indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. - homozygous familial hypercholesterolemia (hofh): ezetimibe teva administered with a statin are indicated for use in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).- homozygous sitosterolemia (phytosterolemia): ezetimibe teva is indicated for use in patients with homozygous familial sitosterolemia

Australie - anglais - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: crospovidone; colloidal anhydrous silica; lactose monohydrate; stearic acid; sodium lauryl sulfate; povidone - adults (greater than or equal to 18 years),primary hypercholesterolaemia,ezetimibe gh 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),ezetimibe gh, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia) ezetimibe gh is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. prevention of cardiovascular disease,ezetimibe gh 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 section 5.1 pharmacodynamic properties ? 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),ezetimibe gh 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),ezetimibe gh 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 (eg. ldl apheresis).

Irlande - anglais - HPRA (Health Products Regulatory Authority)

apotex europe b.v. - ezetimibe - tablets - 10 milligram - ezetimibe

États-Unis - anglais - NLM (National Library of Medicine)

ascend laboratories, llc - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24), simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - 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. ezetimibe and simvastatin tablets are indicated for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), triglycerides (tg), and non-high-density lipoprotein cholesterol (non-hdl-c), and to increase high-density lipoprotein cholesterol (hdl-c) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.  ezetimibe and simvastatin tablets are indicated for the reduction of elevated total-c and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments