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

remedyrepack inc. - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - 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)

qpharma inc - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - 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: risk summary rosuvastati

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

remedyrepack inc. - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - 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)

scov3 llc - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73), ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - rosuvastatin and ezetimibe tablets is indicated in adults: - as an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (ldl-c). - alone or as an adjunct to other ldl-c-lowering therapies in patients with homozygous familial hypercholesterolemia (hofh) to reduce ldl-c. rosuvastatin and ezetimibe tablets is contraindicated in patients with: - acute liver failure or decompensated cirrhosis. - hypersensitivity to rosuvastatin, ezetimibe, or any excipients in rosuvastatin and ezetimibe tablets. hypersensitivity reactions including anaphylaxis, angioedema, and erythema multiforme have been reported [see adverse reactions (6)] . risk summary discontinue rosuvastatin and ezetimibe tablets when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. rosuvastatin and ezetimibe tablets decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore,

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

arrow pharma pty ltd - rosuvastatin calcium -

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

arrow pharma pty ltd - rosuvastatin calcium -

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

arrow pharma pty ltd - rosuvastatin calcium -

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

arrow pharma pty ltd - rosuvastatin calcium -

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

actavis pharma, inc. - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - ezetimibe tablets are indicated: - in combination with a statin, or alone when additional low-density lipoprotein cholesterol (ldl-c) lowering therapy is not possible, as an adjunct to diet to reduce elevated ldl-c in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh). - in combination with a statin as an adjunct to diet to reduce elevated ldl-c in pediatric patients 10 years of age and older with hefh. - in combination with fenofibrate as an adjunct to diet to reduce elevated ldl-c in adults with mixed hyperlipidemia. - in combination with a statin, and other ldl-c lowering therapies, to reduce elevated ldl-c levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (hofh). - as an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. when ezetimibe tablets are used in combinat

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva b.v. - ezetimibe 10 mg; rosuvastatin calcium 10,4 mg - eq. rosuvastatin 10 mg - tablet - 10 mg - 10 mg - rosuvastatin calcium 10.4 mg; ezetimibe 10 mg - rosuvastatin and ezetimibe