Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - atorvastatin calcium trihydrate - oral tablet - 10mg

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

pharmacor pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: sodium lauryl sulfate; lactose monohydrate; magnesium stearate; microcrystalline cellulose; crospovidone; hypromellose; croscarmellose sodium - adults (? 18 years) primary hypercholesterolaemia,akm ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),akm ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),akm ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,akm ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year postmenarche),heterozygous familial hypercholesterolaemia (hefh),akm ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),akm ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

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

pharmacor pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; hypromellose; crospovidone; lactose monohydrate; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate - adults (? 18 years) primary hypercholesterolaemia,akm ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),akm ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),akm ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,akm ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year postmenarche),heterozygous familial hypercholesterolaemia (hefh),akm ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),akm ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

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

pharmacor pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; hypromellose; lactose monohydrate; croscarmellose sodium; crospovidone; magnesium stearate - adults (? 18 years) primary hypercholesterolaemia,pharmacor ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),pharmacor ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),pharmacor ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,pharmacor ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year postmenarche),heterozygous familial hypercholesterolaemia (hefh),pharmacor ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),pharmacor ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

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

pharmacor pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; lactose monohydrate; crospovidone; hypromellose; magnesium stearate - adults (? 18 years) primary hypercholesterolaemia,pharmacor ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),pharmacor ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),pharmacor ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,pharmacor ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year postmenarche),heterozygous familial hypercholesterolaemia (hefh),pharmacor ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),pharmacor ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

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

sandoz pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: hypromellose; lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose - adults (? 18 years),primary hypercholesterolaemia,ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),ezetimibe, is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in risk of cardiovascular events following at least one year therapy (see section 5.1 pharmacodynamic properties, clinical trials),children and adolescents 10-17 years,(pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

Israel - engelsk - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 40 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - engelsk - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 80 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - engelsk - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 10 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - engelsk - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 20 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.