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

avallon pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 20.791 mg - tablet, film coated - excipient ingredients: macrogol 6000; hypromellose; silicon dioxide; microcrystalline cellulose; sodium stearylfumarate; lactose; colloidal anhydrous silica; purified talc; maize starch; mannitol - 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)

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)

avallon pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 5.198 mg - tablet, film coated - excipient ingredients: hypromellose; maize starch; sodium stearylfumarate; colloidal anhydrous silica; silicon dioxide; mannitol; lactose; microcrystalline cellulose; purified talc; 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

newline pharma s.l. - rosuvastatin (as calcium) - film-coated tablet - 5 milligram(s) - hmg coa reductase inhibitors; rosuvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

newline pharma s.l. - rosuvastatin (as calcium) - film-coated tablet - 10 milligram(s) - hmg coa reductase inhibitors; rosuvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

newline pharma s.l. - rosuvastatin (as calcium) - film-coated tablet - 20 milligram(s) - hmg coa reductase inhibitors; rosuvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

newline pharma s.l. - rosuvastatin (as calcium) - film-coated tablet - 40 milligram(s) - hmg coa reductase inhibitors; rosuvastatin

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

jubilant cadista 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 is contraindicated in the following conditions: - patients with a known hypersen

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

preferred pharmaceuticals, inc. - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - rosuvastatin 40 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 tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin 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 tablets have not been studied in fredrickson type i and v dyslipidemias. rosuvastatin tablets are contraindicated in the following conditions:    risk summary rosuvastatin is contraindicated for use in pre

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