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

torrent australasia pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: ferric oxide; ascorbic acid; magnesium stearate; lactose monohydrate; hypromellose; microcrystalline cellulose; croscarmellose sodium; citric acid monohydrate; butylated hydroxyanisole; propyl gallate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,apo-ezetimine/simvastatin 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,apo-ezetimine/simvastatin 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),apo-ezetimine/simvastatin 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),apo-ezetimine/simvastatin 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),apo-ezetimine/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

generic health pty ltd - atorvastatin calcium, quantity: 41.36 mg (equivalent: atorvastatin, qty 40 mg) - tablet, film coated - excipient ingredients: hyprolose; hypromellose; lactose monohydrate; magnesium stearate; colloidal anhydrous silica; macrogol 4000; titanium dioxide; pregelatinised maize starch; microcrystalline cellulose; activated attapulgite - 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. hypertensive patients with multiple risk factors for chd which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see actions, clinical trials, prevention of cardiovascular disease) to reduce the risk of nonfatal mi and nonfatal stroke.,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 - atorvastatin calcium, quantity: 82.72 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: magnesium stearate; pregelatinised maize starch; activated attapulgite; hyprolose; colloidal anhydrous silica; lactose monohydrate; hypromellose; microcrystalline cellulose; macrogol 4000; titanium dioxide - 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. hypertensive patients with multiple risk factors for chd which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see actions, clinical trials, prevention of cardiovascular disease) to reduce the risk of nonfatal mi and nonfatal stroke.,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 - atorvastatin calcium, quantity: 10.34 mg (equivalent: atorvastatin, qty 10 mg) - tablet, film coated - excipient ingredients: hypromellose; macrogol 4000; magnesium stearate; titanium dioxide; lactose monohydrate; colloidal anhydrous silica; hyprolose; microcrystalline cellulose; pregelatinised maize starch; activated attapulgite - 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. hypertensive patients with multiple risk factors for chd which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see actions, clinical trials, prevention of cardiovascular disease) to reduce the risk of nonfatal mi and nonfatal stroke.,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 - atorvastatin calcium, quantity: 20.68 mg (equivalent: atorvastatin, qty 20 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; macrogol 4000; pregelatinised maize starch; activated attapulgite; magnesium stearate; hypromellose; titanium dioxide; microcrystalline cellulose; colloidal anhydrous silica; hyprolose - 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. hypertensive patients with multiple risk factors for chd which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see actions, clinical trials, prevention of cardiovascular disease) to reduce the risk of nonfatal mi and nonfatal stroke.,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)

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

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

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

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - pravastatin sodium 10mg - tablet - 10 mg - active: pravastatin sodium 10mg excipient: croscarmellose sodium iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose - in hypercholesterolemic patients without clinically evident coronary heart disease, pravastatin is indicated as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths.

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - pravastatin sodium 20mg - tablet - 20 mg - active: pravastatin sodium 20mg excipient: croscarmellose sodium iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose - in hypercholesterolemic patients without clinically evident coronary heart disease, pravastatin is indicated as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths.

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - pravastatin sodium 40mg - tablet - 40 mg - active: pravastatin sodium 40mg excipient: brilliant blue fcf croscarmellose sodium iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose - in hypercholesterolemic patients without clinically evident coronary heart disease, pravastatin is indicated as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths.