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

sandoz pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; butylated hydroxyanisole; iron oxide black; iron oxide yellow; ascorbic acid; lactose monohydrate; microcrystalline cellulose; hypromellose; citric acid; iron oxide red; propyl gallate; croscarmellose sodium - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-sandoz 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 clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-sandoz 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) ezetimibe/simvastatin-sandoz is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., 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) ezetimibe/simvastatin-sandoz is indicated as 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/simvastatin-sandoz is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

sandoz pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; butylated hydroxyanisole; iron oxide yellow; citric acid; iron oxide red; magnesium stearate; propyl gallate; lactose monohydrate; hypromellose; ascorbic acid; iron oxide black - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-sandoz 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 clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-sandoz 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) ezetimibe/simvastatin-sandoz is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., 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) ezetimibe/simvastatin-sandoz is indicated as 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/simvastatin-sandoz is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Israel - English - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 20 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures. - reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvastatin-teva is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvastatin-teva is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Israel - English - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 10 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures.- reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvastatin-teva is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios.homozygous familial hypercholesterolemia: simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvastatin-teva is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Israel - English - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 80 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva is indicated to: reduce the risk of total mortality by reducing coronary death reduce the risk of non-fatal myocardial infarction reduce the risk for undergoing myocardial revascularization procedures.reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvastatin-teva is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvastatin-teva is indicated for the treatment of patients with hypertriglyceridemia (fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvastatin-teva is also indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Israel - English - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 40 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva is indicated to: reduce the risk of total mortality by reducing coronary death ;reduce the risk of non-fatal myocardial infarction ;reduce the risk for undergoing myocardial revascularization procedures. reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvastatin-teva is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvastatin-teva is indicated for the treatment of patients with hypertriglyceridemia ( fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvastatin-teva is also indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Malta - English - Medicines Authority

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

Malta - English - Medicines Authority

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

Malta - English - Medicines Authority

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

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

pharmacor pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; lactose monohydrate; citric acid monohydrate; propyl gallate; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; butylated hydroxyanisole; hypromellose - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets 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.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets 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),ezetimibe and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., 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),ezetimibe and simvastatin tablets is indicated as 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 and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).