오스트레일리아 - 영어 - 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)

오스트레일리아 - 영어 - 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)

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - ibuprofen, quantity: 200 mg; paracetamol, quantity: 500 mg - tablet, film coated - excipient ingredients: titanium dioxide; povidone; purified water; microcrystalline cellulose; hypromellose; purified talc; magnesium stearate; crospovidone; colloidal anhydrous silica; pregelatinised maize starch; polysorbate 80; polyvinyl alcohol; macrogol 3350; mica - temporary relief of acute (short term) pain and / or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains associated with colds and flu. reduces fever.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

gm pharma international pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to 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 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 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)

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to 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 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 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)

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to18 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 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 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)

오스트레일리아 - 영어 - 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).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: crospovidone; colloidal anhydrous silica; lactose monohydrate; stearic acid; sodium lauryl sulfate; 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).

오스트레일리아 - 영어 - 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).

오스트레일리아 - 영어 - 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).