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

mylan institutional 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 tabl

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

remedyrepack inc. - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - rosuvastatin 20 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:    - patients with a known hypersensitivity to an

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

aphena pharma solutions - tennessee, llc - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - rosuvastatin 10 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: - patients with a known

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

acetris health, llc - 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: - patients with a known

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

par pharmaceutical, 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 has not been studied in fredrickson type i and v dyslipidemias. rosuvastatin calcium tablets are contraindicated in the following conditions: - patients with a known hypersensitivity

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

remedyrepack 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: - patients with a known

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

sandoz 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: rosuvastatin calcium tablets are contraindicated in the following conditions: risk summary discontinue rosuvastatin when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)]. in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on th

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.

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

accord healthcare pty ltd - rosuvastatin calcium, quantity: 5.21 mg - tablet, film coated - excipient ingredients: light magnesium oxide; crospovidone; microcrystalline cellulose; lactose; magnesium stearate; hypromellose; triacetin; titanium dioxide; lactose monohydrate; iron oxide yellow - 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: crospovidone; lactose; magnesium stearate; microcrystalline cellulose; light magnesium oxide; 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.