Irlanda - engleză - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - simvastatin - film-coated tablet - 10 milligram(s) - hmg coa reductase inhibitors; simvastatin

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - simvastatin; ezetimibe - tablet - 10/10 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

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

sandoz pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: ascorbic acid; iron oxide red; microcrystalline cellulose; lactose monohydrate; magnesium stearate; croscarmellose sodium; butylated hydroxyanisole; iron oxide black; propyl gallate; hypromellose; iron oxide yellow; citric acid - 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 - engleză - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - simvastatin, quantity: 80 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; propyl gallate; croscarmellose sodium; butylated hydroxyanisole; ascorbic acid; citric acid monohydrate; microcrystalline cellulose; hypromellose; magnesium stearate; ferric oxide - 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 - engleză - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: ferric oxide; ascorbic acid; magnesium stearate; lactose monohydrate; hypromellose; microcrystalline cellulose; croscarmellose sodium; citric acid monohydrate; butylated hydroxyanisole; 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).

Spania - spaniolă - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

viatris limited - simvastatina; ezetimiba - comprimido - 20 mg/10 mg - simvastatina 20 mg; ezetimiba 10 mg - simvastatina y ezetimiba

Spania - spaniolă - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

viatris limited - simvastatina; ezetimiba - comprimido - 40 mg/10 mg - simvastatina 40 mg; ezetimiba 10 mg - simvastatina y ezetimiba

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - ezetimibe; simvastatin - tablet - 10 mg/40 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe - reductase inhibitors in combination with other lipid modifying agents - it is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familiar and non-familiar) hypercholesterolaemia or mixed hyperlipidaemia, and in patient with hofh

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - ezetimibe; simvastatin - tablet - 10mg/20 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe - reductase inhibitors in combination with other lipid modifying agents - it is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familiar and non-familiar) hypercholesterolaemia or mixed hyperlipidaemia, and in patient with hofh

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

remedyrepack inc. - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 20 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. in patients with coronary heart disease (chd) or at high risk of chd, simvastatin tablets usp can be started simultaneously with diet. in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets usp are indicated to: - reduce the risk of total mortality by reducing chd deaths. - reduce the risk of non-fatal myocardial infarction and stroke. - reduce the need for coronary and non-coronary revascularization procedures. simvastatin tablets usp are indicated to: - reduce elevated total cho