Australia - English - 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 - English - 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 - English - 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)

Australia - English - 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)

Australia - English - 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)

Australia - English - 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)

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

merck sharp & dohme (australia) pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: hypromellose acetate succinate; microcrystalline cellulose; hyprolose; silicon dioxide; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - noxafil (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older; invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy; fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. noxafil is also indicated for the: treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. prophylaxis of invasive fungal infections, among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

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

dr reddys laboratories australia pty ltd - olanzapine, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; magnesium stearate; hyprolose; titanium dioxide; hypromellose; macrogol 400 - treatment of schizophrenia and related psychoses. short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder. preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

dr reddys laboratories australia pty ltd - olanzapine, quantity: 7.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; magnesium stearate; hyprolose; titanium dioxide; hypromellose; macrogol 400 - treatment of schizophrenia and related psychoses. short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder. preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

dr reddys laboratories australia pty ltd - olanzapine, quantity: 5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; magnesium stearate; hyprolose; titanium dioxide; hypromellose; macrogol 400 - treatment of schizophrenia and related psychoses. short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder. preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.