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

sun pharma anz pty ltd - fenofibrate, quantity: 48 mg - tablet - excipient ingredients: sucrose; pregelatinised maize starch; silicon dioxide; sodium lauryl sulfate; sodium stearylfumarate; hypromellose; crospovidone; microcrystalline cellulose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - fenofibrate is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.

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

sun pharma anz pty ltd - fenofibrate, quantity: 145 mg - tablet - excipient ingredients: pregelatinised maize starch; sodium stearylfumarate; crospovidone; sodium lauryl sulfate; silicon dioxide; microcrystalline cellulose; hypromellose; sucrose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - fenofibrate is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - rosuvastatin 5 mg - pediatric use information for patients 7 to 17 years of age is approved for astrazeneca’s crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., ldl apheresis) or alone if such treatments are unavailable to reduce ldl-c, total-c, and apob in adult patients with homozygous familial hypercholesterolemia. rosuvastatin calcium tablets have not been studied in fredrickson type i and v dyslipidemias. rosuvastatin calcium tablets are contraindicated in the following conditions: rosuvastatin calcium tab

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 41.581 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium citrate dihydrate; magnesium stearate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - 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 (excluding heterozygous 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.

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 20.79 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium citrate dihydrate; magnesium stearate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - 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 (excluding heterozygous 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.

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 5.198 mg - tablet, film coated - excipient ingredients: crospovidone; lactose monohydrate; microcrystalline cellulose; sodium citrate dihydrate; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - 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 (excluding heterozygous 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.

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 10.395 mg - tablet, film coated - excipient ingredients: sodium citrate dihydrate; magnesium stearate; lactose monohydrate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - 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 (excluding heterozygous 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.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - rosuvastatin 20 mg - rosuvastatin calcium tablets are indicated as an adjunct to diet to: ●       reduce ldl-c, total-c, non-hdl-c and apo-b in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., ldl apheresis). pediatric use information for patients ages 8 to less than 10 years is approved for astrazeneca’s crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., ldl apheresis) or alone if such treatments are unavaila

United States - English - NLM (National Library of Medicine)

major pharmaceuticals - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - rosuvastatin 5 mg - rosuvastatin calcium tablets are indicated as an adjunct to diet to: pediatric use information for patients ages 8 to less than 10 years is approved for astrazeneca’s crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., ldl apheresis) or alone if such treatments are unavailable to reduce ldl-c, total-c, and apob in adult patients with homozygous familial hypercholesterolemia. rosuvastatin calcium tablets have not been studied in fredrickson type i and v dyslipidemias. rosuvastatin calcium tabl

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.