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

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 86.8 mg (equivalent: atorvastatin, qty 80 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; povidone; hyprolose; silicon dioxide; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 clinical trials). primary hypercholesterolaemia atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

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

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 10.9 mg (equivalent: atorvastatin, qty 10 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: hyprolose; povidone; microcrystalline cellulose; magnesium stearate; silicon dioxide; lactose monohydrate; croscarmellose sodium; calcium carbonate; sodium lauryl sulfate; polysorbate 80; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 clinical trials).,primary hypercholesterolaemia atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe,homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

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

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 21.7 mg (equivalent: atorvastatin, qty 20 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; sodium lauryl sulfate; silicon dioxide; povidone; magnesium stearate; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 clinical trials). primary hypercholesterolaemia atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

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

lupin australia pty limited - atorvastatin calcium trihydrate, quantity: 82.725 mg (equivalent: atorvastatin, qty 80 mg); ezetimibe, quantity: 10 mg - tablet, film coated - excipient ingredients: calcium carbonate; crospovidone; microcrystalline cellulose; hyprolose; lactose monohydrate; sodium lauryl sulfate; sodium stearylfumarate; colloidal anhydrous silica; povidone; lactose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - prevention of cardiovascular disease ezetimibe/atorvastatin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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,primary hypercholesterolaemia ezetimibe/atorvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: ? not appropriately controlled with atorvastatin or ezetimibe alone; or ? already treated with atorvastatin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh) ezetimibe/atorvastatin is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

lupin australia pty limited - atorvastatin calcium trihydrate, quantity: 10.341 mg (equivalent: atorvastatin, qty 10 mg); ezetimibe, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose; colloidal anhydrous silica; crospovidone; sodium lauryl sulfate; sodium stearylfumarate; microcrystalline cellulose; povidone; lactose monohydrate; calcium carbonate; hyprolose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - prevention of cardiovascular disease ezetimibe/atorvastatin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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,primary hypercholesterolaemia ezetimibe/atorvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: ? not appropriately controlled with atorvastatin or ezetimibe alone; or ? already treated with atorvastatin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh) ezetimibe/atorvastatin is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

lupin australia pty limited - atorvastatin calcium trihydrate, quantity: 20.681 mg (equivalent: atorvastatin, qty 20 mg); ezetimibe, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium stearylfumarate; lactose; colloidal anhydrous silica; hyprolose; sodium lauryl sulfate; crospovidone; calcium carbonate; povidone; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - prevention of cardiovascular disease ezetimibe/atorvastatin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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,primary hypercholesterolaemia ezetimibe/atorvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: ? not appropriately controlled with atorvastatin or ezetimibe alone; or ? already treated with atorvastatin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh) ezetimibe/atorvastatin is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

organon pharma pty ltd - ezetimibe, quantity: 10 mg; atorvastatin calcium trihydrate, quantity: 43.4 mg (equivalent: atorvastatin, qty 40 mg) - tablet, multilayer - excipient ingredients: hyprolose; lactose monohydrate; croscarmellose sodium; silicon dioxide; magnesium stearate; microcrystalline cellulose; povidone; polysorbate 80; sodium lauryl sulfate; calcium carbonate; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 clinical trials). primary hypercholesterolaemia atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

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

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 86.76 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; calcium carbonate; hyprolose; microcrystalline cellulose; polysorbate 80; croscarmellose sodium; titanium dioxide; macrogol 8000; hypromellose; purified talc; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate - 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.

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

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 43.38 mg (equivalent: atorvastatin, qty 40 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; polysorbate 80; croscarmellose sodium; magnesium stearate; hyprolose; candelilla wax; calcium carbonate; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - 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.

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

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 21.69 mg (equivalent: atorvastatin, qty 20 mg) - tablet, film coated - excipient ingredients: candelilla wax; lactose monohydrate; croscarmellose sodium; polysorbate 80; hyprolose; magnesium stearate; calcium carbonate; microcrystalline cellulose; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - 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.