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

torrent australasia pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 20 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; hypromellose; butylated hydroxyanisole; ferric oxide; ascorbic acid; citric acid monohydrate; lactose monohydrate; propyl gallate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,apo-ezetimine/simvastatin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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),primary hypercholesterolaemia,apo-ezetimine/simvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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),apo-ezetimine/simvastatin is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,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),apo-ezetimine/simvastatin is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),apo-ezetimine/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

torrent australasia pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: ferric oxide; hypromellose; lactose monohydrate; ascorbic acid; croscarmellose sodium; butylated hydroxyanisole; microcrystalline cellulose; magnesium stearate; citric acid monohydrate; propyl gallate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,apo-ezetimine/simvastatin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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),primary hypercholesterolaemia,apo-ezetimine/simvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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),apo-ezetimine/simvastatin is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,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),apo-ezetimine/simvastatin is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),apo-ezetimine/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

Singapura - Inggeris - HSA (Health Sciences Authority)

organon singapore pte. ltd. - ezetimibe - tablet - 10 mg - ezetimibe 10 mg

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

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to 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 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 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)

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

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to18 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 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 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)

Malta - Inggeris - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - ezetimibe, simvastatin - tablet - ezetimibe 10 mg simvastatin 40 mg - lipid modifying agents

Malta - Inggeris - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - ezetimibe, simvastatin - tablet - ezetimibe 10 mg simvastatin 20 mg - lipid modifying agents

Malta - Inggeris - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - ezetimibe, simvastatin - tablet - ezetimibe 10 mg simvastatin 40 mg - lipid modifying agents

Malta - Inggeris - Medicines Authority

zentiva k.s. u kabelovny 130, dolní mecholupy, 102 37 praha 10, czech republic - ezetimibe - tablet - ezetimibe 10 mg - lipid modifying agents

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

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