New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 40mg;   - film coated tablet - 40 mg - active: simvastatin 40mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate starch, pregelatinised (starch 1500) lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 20a54211 - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 5mg;   - film coated tablet - 5 mg - active: simvastatin 5mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow 20a52229 starch - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 80mg;   - film coated tablet - 80 mg - active: simvastatin 80mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate starch, pregelatinised (starch 1500) lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 20a54211 - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

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

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 80 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; ascorbic acid; pregelatinised maize starch; citric acid monohydrate; microcrystalline cellulose; butylated hydroxyanisole; titanium dioxide; hypromellose; purified talc; iron oxide red; hyetellose - simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg 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 chd (coronary heart disease) (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 - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 40 mg - tablet, film coated - excipient ingredients: ascorbic acid; magnesium stearate; microcrystalline cellulose; citric acid monohydrate; lactose monohydrate; pregelatinised maize starch; butylated hydroxyanisole; titanium dioxide; hypromellose; purified talc; iron oxide red; hyetellose - simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg 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 chd (coronary heart disease) (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 - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 20 mg - tablet, film coated - excipient ingredients: butylated hydroxyanisole; pregelatinised maize starch; citric acid monohydrate; lactose monohydrate; ascorbic acid; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red - simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg 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 chd (coronary heart disease) (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 - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 10 mg - tablet, film coated - excipient ingredients: magnesium stearate; butylated hydroxyanisole; microcrystalline cellulose; lactose monohydrate; pregelatinised maize starch; ascorbic acid; citric acid monohydrate; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red; iron oxide black - simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg 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 chd (coronary heart disease) (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.

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

bryant ranch prepack - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 20 mg - simvastatin tablet is 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:

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

generic health pty ltd - simvastatin, quantity: 80 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; magnesium stearate; citric acid monohydrate; ascorbic acid; microcrystalline cellulose; lactose monohydrate; butylated hydroxyanisole; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red; iron oxide black - simvastatin generichealth tablets are indicated as an 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 generichealth tablets are 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 hospitilisation 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 generichealth tablets are 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, 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 - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - simvastatin, quantity: 40 mg - tablet, film coated - excipient ingredients: lactose monohydrate; ascorbic acid; citric acid monohydrate; pregelatinised maize starch; butylated hydroxyanisole; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide red; iron oxide black - simvastatin generichealth tablets are indicated as an 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 generichealth tablets are 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 hospitilisation 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 generichealth tablets are 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, 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.