Ireland - English - HPRA (Health Products Regulatory Authority)

teva b.v. - ezetimibe; simvastatin - tablet - 10/80 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

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).

Ireland - English - HPRA (Health Products Regulatory Authority)

key pharmaceuticals ltd - ezetimibe - tablet - 10 milligram(s) - other lipid modifying agents; ezetimibe

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ezetimibe - tablet - 10 milligram(s) - other lipid modifying agents; ezetimibe

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ezetimibe - tablet - 10 milligram(s) - other lipid modifying agents; ezetimibe

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - ezetimibe; simvastatin - tablet - 10 mg/40 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe - reductase inhibitors in combination with other lipid modifying agents - it is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familiar and non-familiar) hypercholesterolaemia or mixed hyperlipidaemia, and in patient with hofh

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - ezetimibe; simvastatin - tablet - 10mg/20 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe - reductase inhibitors in combination with other lipid modifying agents - it is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familiar and non-familiar) hypercholesterolaemia or mixed hyperlipidaemia, and in patient with hofh