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

torrent australasia pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; propyl gallate; croscarmellose sodium; hypromellose; butylated hydroxyanisole; lactose monohydrate; ascorbic acid; ferric oxide; citric acid monohydrate; magnesium stearate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezetorin 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,ezetorin 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),ezetorin 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),ezetorin 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),ezetorin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

torrent australasia pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: citric acid monohydrate; propyl gallate; hypromellose; lactose monohydrate; butylated hydroxyanisole; ferric oxide; ascorbic acid; magnesium stearate; croscarmellose sodium; microcrystalline cellulose - adults (greater than or equal to 18 years),prevention of cardiovascular disease,simtorsi 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,simtorsi 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),simtorsi 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),simtorsi 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),simtorsi is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

torrent australasia pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: croscarmellose sodium; lactose monohydrate; citric acid monohydrate; magnesium stearate; propyl gallate; hypromellose; microcrystalline cellulose; ferric oxide; ascorbic acid; butylated hydroxyanisole - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezsimva gh 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,ezsimva gh 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),ezsimva gh s 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),ezsimva gh 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),ezsimva gh is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - ezetimibe 10mg; simvastatin 20mg - tablet - 10/20mg - active: ezetimibe 10mg simvastatin 20mg excipient: butylated hydroxyanisole citric acid monohydrate croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose propyl gallate - homozygous familial hypercholesterolaemia vytorin is indicated for the reduction of elevated total-c and ldl-c levels in adult and adolescent (10 to 17 years of age) patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Israele - inglese - 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).

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

rosemont pharmaceuticals ltd - simvastatin - oral suspension - 20 mg/5ml - hmg coa reductase inhibitors

Malta - inglese - Medicines Authority

merck sharp & dohme limited hertford road, hoddesdon, hertfordshire en11 9bu, united kingdom - ezetimibe, simvastatin - tablet - ezetimibe 10 mg simvastatin 20 mg - lipid modifying agents

Malta - inglese - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - simvastatin - film-coated tablet - simvastatin 20 mg - lipid modifying agents

Regno Unito - inglese - myHealthbox

caduceus pharma ltd - simvastatin - film-coated tablets - 20mg - hmg-coa reductase inhibitors - hypercholesterolaemia treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate treatment of homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid-lowering treatments (e.g. ldl apheresis) or if such treatments are not appropriate. cardiovascular prevention reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg; simvastatin 20mg;   - tablet - 10mg/20mg - active: ezetimibe 10mg simvastatin 20mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate - primary hypercholesterolaemia zimybe 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), triglycerides (tg), and non high-density lipoprotein cholesterol (non-hdl-c), 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 or mixed hyperlipidaemia in patients not adequately treated on a statin alone. homozygous familial hypercholesterolaemia (hofh) zimybe is indicated for the reduction of elevated total-c and ldl-c levels in adult and adolescent (10 to 17 years of age) patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).