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

avallon pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 10.396 mg - tablet, film coated - excipient ingredients: lactose; colloidal anhydrous silica; maize starch; hypromellose; sodium stearylfumarate; microcrystalline cellulose; silicon dioxide; purified talc; mannitol; macrogol 6000 - noumed rosuvastatin is indicated as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events: noumed 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). noumed 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 noumed rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding familial hypercholesterolaemia). prior to initiating therapy with noumed 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.

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

sandoz pty ltd - rosuvastatin calcium -

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - rosuvastatin calcium 10.396mg equivalent to rosuvastatin 10 mg - film coated tablet - 10 mg - active: rosuvastatin calcium 10.396mg equivalent to rosuvastatin 10 mg excipient: colloidal silicon dioxide crospovidone iron oxide red lactose monohydrate light magnesium oxide magnesium stearate microcrystalline cellulose opadry pink - rosuvastatin calcium is indicated to: · reduce elevated ldl-c, total cholesterol, triglycerides and to increase hdlcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (fredrickson types iia and iib). rosuvastatin calcium also lowers apob, nonhdl-c, vldl-c, vldl-tg, the ldl-c/hdl-c, total c/hdl-c, nonhdl-c/hdl-c, apob/apoa-i ratios and increase apo-a-i in these populations. · treat isolated hypertriglyceridaemia (fredrickson type iv hyperlipidaemia). · reduce total cholesterol and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or alone if such treatments are unavailable.

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

pharmacor pty ltd - rosuvastatin calcium, quantity: 10.4 mg (equivalent: rosuvastatin, qty 10 mg) - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; lactose monohydrate; light magnesium oxide; crospovidone; titanium dioxide; hypromellose; triacetin; iron oxide red - primary hypercholesterolaemiapharmacor ezetimibe rosuvastatin 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),pharmacor ezetimibe rosuvastatin composite pack is indicated for 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 - 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).

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

organon pharma pty ltd - rosuvastatin calcium, quantity: 10.396 mg - tablet, film coated - excipient ingredients: hypromellose; sodium stearylfumarate; lactose; colloidal anhydrous silica; purified talc; maize starch; macrogol 6000; mannitol; microcrystalline cellulose; 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).

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

generic health pty ltd - rosuvastatin calcium, quantity: 10.42 mg - tablet, film coated - excipient ingredients: lactose; magnesium stearate; crospovidone; microcrystalline cellulose; light magnesium oxide; titanium dioxide; lactose monohydrate; hypromellose; triacetin; brilliant blue fcf aluminium lake; iron oxide red; quinoline yellow aluminium lake - rosuvastatin lupin should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,prevention of cardiovascular events rosuvastatin lupin is indicated for prevention of major cardiovascular events in men ?50 years old and women ?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 lupin 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 lupin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,prior to initiating therapy with rosuvastatin lupin , 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)

pharmacor pty ltd - rosuvastatin calcium, quantity: 10.4 mg (equivalent: rosuvastatin, qty 10 mg) - tablet, film coated - excipient ingredients: light magnesium oxide; magnesium stearate; lactose monohydrate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; triacetin; iron oxide red - primary hypercholesterolaemia,ezecrest 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),ezecrest composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

fair-med healthcare australia pty ltd - rosuvastatin calcium -

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

pharmacor pty ltd - rosuvastatin calcium, quantity: 10.42 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; lactose; magnesium stearate; light magnesium oxide; titanium dioxide; lactose monohydrate; hypromellose; triacetin; brilliant blue fcf aluminium lake; iron oxide red; quinoline yellow aluminium lake - pharmacor rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,prevention of cardiovascular events pharmacor rosuvastatin is indicated for prevention of major cardiovascular events in men ?50 years old and women ?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). pharmacor 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 pharmacor rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,prior to initiating therapy with pharmacor 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.