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

sandoz pty ltd - simvastatin, quantity: 40 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; citric acid monohydrate; lactose monohydrate; purified talc; ascorbic acid; hypromellose; pregelatinised maize starch; butylated hydroxyanisole; titanium dioxide; iron oxide red; magnesium stearate - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-

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

sandoz pty ltd - simvastatin, quantity: 20 mg - tablet, film coated - excipient ingredients: magnesium stearate; iron oxide yellow; titanium dioxide; citric acid monohydrate; purified talc; ascorbic acid; lactose monohydrate; hypromellose; microcrystalline cellulose; pregelatinised maize starch; iron oxide red; butylated hydroxyanisole - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-

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

sandoz pty ltd - simvastatin, quantity: 10 mg - tablet, film coated - excipient ingredients: citric acid monohydrate; lactose monohydrate; titanium dioxide; ascorbic acid; hypromellose; purified talc; microcrystalline cellulose; iron oxide yellow; pregelatinised maize starch; iron oxide red; magnesium stearate; butylated hydroxyanisole - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-

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

sandoz pty ltd - simvastatin, quantity: 5 mg - tablet, film coated - excipient ingredients: magnesium stearate; ascorbic acid; lactose monohydrate; pregelatinised maize starch; titanium dioxide; microcrystalline cellulose; purified talc; butylated hydroxyanisole; citric acid monohydrate; hypromellose; iron oxide yellow - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-

United States - English - NLM (National Library of Medicine)

micro labs limited - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 5 mg - simvastatin tablets are indicated: • to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. • as an adjunct to diet to reduce low-density lipoprotein cholesterol (ldl-c):       o in adults with primary hyperlipidemia.       o in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (hefh). • as an adjunct to other ldl-c-lowering therapies to reduce ldl-c in adults with homozygous familial hypercholesterolemia (hofh). • as an adjunct to diet for the treatment of adults with:       o primary dysbetalipoproteinemia.       o hypertriglyceridemia. simvastatin tablets are contraindicated in th

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

dr reddys laboratories australia pty ltd - simvastatin, quantity: 40.005 mg - tablet - excipient ingredients: butylated hydroxyanisole; magnesium stearate; lactose monohydrate; ascorbic acid; microcrystalline cellulose; pregelatinised maize starch; citric acid; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black - simvastatin-drla is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin-drla, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin-drla is indicated in patients at high risk of chd (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin-drla is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-mena

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

dr reddys laboratories australia pty ltd - simvastatin, quantity: 80.1 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; citric acid; pregelatinised maize starch; microcrystalline cellulose; butylated hydroxyanisole; ascorbic acid; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black - simvastatin-drla is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin-drla, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin-drla is indicated in patients at high risk of chd (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin-drla is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-mena

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

dr reddys laboratories australia pty ltd - simvastatin, quantity: 20 mg - tablet - excipient ingredients: microcrystalline cellulose; butylated hydroxyanisole; pregelatinised maize starch; lactose monohydrate; ascorbic acid; citric acid; magnesium stearate; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black - simvastatin-drla is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin-drla, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin-drla is indicated in patients at high risk of chd (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin-drla is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-mena

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

dr reddys laboratories australia pty ltd - simvastatin, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; citric acid; ascorbic acid; butylated hydroxyanisole; pregelatinised maize starch; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black - simvastatin-drla is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin-drla, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin-drla is indicated in patients at high risk of chd (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin-drla is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-mena

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).