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

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

accord healthcare pty ltd - rosuvastatin calcium, quantity: 41.68 mg - tablet, film coated - excipient ingredients: lactose; crospovidone; magnesium stearate; microcrystalline cellulose; light magnesium oxide; titanium dioxide; lactose monohydrate; hypromellose; sunset yellow fcf aluminium lake; triacetin; brilliant blue fcf aluminium lake; allura red ac aluminium lake - apo-rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,prevention of cardiovascular events apo-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). apo-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 apo-rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,prior to initiating therapy with apo-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)

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

accord healthcare pty ltd - rosuvastatin calcium, quantity: 20.84 mg - tablet, film coated - excipient ingredients: light magnesium oxide; lactose; magnesium stearate; microcrystalline cellulose; crospovidone; titanium dioxide; lactose monohydrate; hypromellose; triacetin; brilliant blue fcf aluminium lake; iron oxide red; quinoline yellow aluminium lake - apo-rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,prevention of cardiovascular events apo-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). apo-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 apo-rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,prior to initiating therapy with apo-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)

accord healthcare pty ltd - rosuvastatin calcium, quantity: 41.68 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; light magnesium oxide; lactose; crospovidone; titanium dioxide; lactose monohydrate; hypromellose; sunset yellow fcf aluminium lake; triacetin; brilliant blue fcf aluminium lake; allura red ac aluminium lake - apo-rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,prevention of cardiovascular events apo-rosuvastatinx 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). apo-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 apo-rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,prior to initiating therapy with apo-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.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - rosuvastatin calcium -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - rosuvastatin calcium -

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - ezetimibe; rosuvastatin calcium eqv. rosuvastatin - tablet, film coated - ezetimibe 10.0 mg; rosuvastatin calcium eqv. rosuvastatin 10.0 mg

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - ezetimibe; rosuvastatin calcium eqv. rosuvastatin - tablet, film coated - ezetimibe 10.0 mg; rosuvastatin calcium eqv. rosuvastatin 20.0 mg

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.