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

pharmacor pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; croscarmellose sodium; citric acid monohydrate; butylated hydroxyanisole; magnesium stearate; hypromellose; microcrystalline cellulose; propyl gallate; sodium lauryl sulfate - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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 and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,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 and simvastatin tablets is indicated as 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 and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

lupin australia pty limited - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: sodium lauryl sulfate; colloidal anhydrous silica; stearic acid; crospovidone; lactose monohydrate; povidone - adults (greater than or equal to 18 years),primary hypercholesterolaemia,ezetimibe gh 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 gh, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia) ezetimibe gh is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. prevention of cardiovascular disease,ezetimibe gh 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 post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe gh 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 gh 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 (eg. ldl apheresis).

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

lupin australia pty limited - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: crospovidone; povidone; lactose monohydrate; sodium lauryl sulfate; stearic acid; colloidal anhydrous silica - adults (greater than or equal to 18 years),primary hypercholesterolaemia,ezetimibe gh 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 gh, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia) ezetimibe gh is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. prevention of cardiovascular disease,ezetimibe gh 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 post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe gh 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 gh 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 (eg. ldl apheresis).

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

lupin australia pty limited - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: crospovidone; lactose monohydrate; sodium lauryl sulfate; stearic acid; povidone; colloidal anhydrous silica - adults (greater than or equal to 18 years),primary hypercholesterolaemia,ezetimibe gh 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 gh, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia) ezetimibe gh is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. prevention of cardiovascular disease,ezetimibe gh 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 post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe gh 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 gh 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 (eg. ldl apheresis).

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

lupin australia pty limited - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; crospovidone; sodium lauryl sulfate; lactose monohydrate; stearic acid; povidone - adults (greater than or equal to 18 years),primary hypercholesterolaemia,ezetimibe gh 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 gh, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia) ezetimibe gh is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. prevention of cardiovascular disease,ezetimibe gh 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 post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe gh 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 gh 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 (eg. ldl apheresis).

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

teva b.v. - atorvastatin calcium trihydrate 10,845 mg - eq. atorvastatin 10 mg; ezetimibe 10 mg - film-coated tablet - 10 mg - 10 mg - atorvastatin calcium trihydrate 10.845 mg - atorvastatin and ezetimibe

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - atorvastatin as calcium - tablets - atorvastatin as calcium 10 mg - atorvastatin - atorvastatin - atorvastatin teva 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. atorvastatin teva 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 prese

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - atorvastatin as calcium - tablets - atorvastatin as calcium 20 mg - atorvastatin - atorvastatin - atorvastatin teva 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. atorvastatin teva 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 prese

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - atorvastatin as calcium - tablets - atorvastatin as calcium 40 mg - atorvastatin - atorvastatin - atorvastatin teva 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. atorvastatin teva 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 prese

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - atorvastatin as calcium - tablets - atorvastatin as calcium 80 mg - atorvastatin - atorvastatin - atorvastatin teva 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. atorvastatin teva 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 prese