Australien - Englisch - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - rosuvastatin calcium, quantity: 5.21 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; microcrystalline cellulose; magnesium stearate; crospovidone; lactose monohydrate; titanium dioxide; hypromellose; triacetin; macrogol 3350 - rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events. rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). rosuvastatin is indicated to: - reduce the risk of nonfatal myocardial infarction. - reduce the risk of nonfatal stroke. - reduce the risk of coronary artery revascularisation procedures. in patients with hypercholesterolaemia: rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with rosuvastatin, 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.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 41.7 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; allura red ac aluminium lake; indigo carmine aluminium lake; iron oxide red - crosuva is indicated as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events: crosuva is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). crosuva is indicated to: reduce the risk of nonfatal myocardial infarction; reduce the risk of nonfatal stroke; reduce the risk of coronary artery revascularisation procedures. in patients with hypercholesterolaemia: crosuva is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with crosuva, 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.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 20.8 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; allura red ac aluminium lake; indigo carmine aluminium lake; iron oxide red - crosuva is indicated as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events: crosuva is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). crosuva is indicated to: reduce the risk of nonfatal myocardial infarction; reduce the risk of nonfatal stroke; reduce the risk of coronary artery revascularisation procedures. in patients with hypercholesterolaemia: crosuva is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with crosuva, 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.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 10.4 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; lactose monohydrate; crospovidone; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; allura red ac aluminium lake; indigo carmine aluminium lake; iron oxide red - crosuva is indicated as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events: crosuva is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). crosuva is indicated to: reduce the risk of nonfatal myocardial infarction; reduce the risk of nonfatal stroke; reduce the risk of coronary artery revascularisation procedures. in patients with hypercholesterolaemia: crosuva is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with crosuva, 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.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 5.2 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; crospovidone; lactose monohydrate; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; quinoline yellow aluminium lake; indigo carmine aluminium lake; iron oxide yellow - crosuva is indicated as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events: crosuva is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). crosuva is indicated to: reduce the risk of nonfatal myocardial infarction; reduce the risk of nonfatal stroke; reduce the risk of coronary artery revascularisation procedures. in patients with hypercholesterolaemia: crosuva is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with crosuva, 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.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - rosuvastatin calcium, quantity: 10.396 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium stearylfumarate; purified talc; macrogol 6000; lactose; colloidal anhydrous silica; maize starch; mannitol; hypromellose; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: rosuzet composite pack 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 rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe. homozygous familial hypercholesterolaemia (hofh): rosuzet composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - rosuvastatin calcium, quantity: 5.198 mg - tablet, film coated - excipient ingredients: hypromellose; sodium stearylfumarate; macrogol 6000; mannitol; maize starch; lactose; microcrystalline cellulose; purified talc; colloidal anhydrous silica; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: ezalo composite pack 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 rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh): ezalo composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - rosuvastatin calcium, quantity: 20.791 mg - tablet, film coated - excipient ingredients: maize starch; colloidal anhydrous silica; lactose; mannitol; purified talc; sodium stearylfumarate; macrogol 6000; microcrystalline cellulose; hypromellose; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: rosuzet composite pack 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 rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe. homozygous familial hypercholesterolaemia (hofh): rosuzet composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - rosuvastatin calcium, quantity: 20.791 mg - tablet, film coated - excipient ingredients: maize starch; colloidal anhydrous silica; macrogol 6000; microcrystalline cellulose; lactose; sodium stearylfumarate; purified talc; hypromellose; mannitol; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: ezalo composite pack 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 rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh): ezalo composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - rosuvastatin calcium, quantity: 5.198 mg - tablet, film coated - excipient ingredients: mannitol; purified talc; macrogol 6000; lactose; hypromellose; microcrystalline cellulose; maize starch; colloidal anhydrous silica; sodium stearylfumarate; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: rosuzet composite pack 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 rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe. homozygous familial hypercholesterolaemia (hofh): rosuzet composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).