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

dr reddys laboratories australia pty ltd - rosuvastatin calcium -

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

generic health pty ltd - pravastatin sodium, quantity: 80 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin generichealth, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. pravastatin generichealth is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin generichealth is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin generichealth is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

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

arrotex pharmaceuticals pty ltd - atorvastatin calcium, quantity: 10.34 mg (equivalent: atorvastatin, qty 10 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; hyprolose; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; activated attapulgite; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000 - as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - simvastatin - oral tablet - 10mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - simvastatin - oral tablet - 10mg