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

amneal pharma australia pty ltd - simvastatin, quantity: 5 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; butylated hydroxyanisole; lactose monohydrate; citric acid monohydrate; ascorbic acid; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, 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 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, 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.

Australia - engelsk - 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 - engelsk - 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 - engelsk - 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 - engelsk - 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

Australia - engelsk - 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, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). 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.

Australia - engelsk - 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, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). 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.

Australia - engelsk - 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, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). 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.

Australia - engelsk - 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, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). 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.

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

amneal pharma australia pty ltd - simvastatin -