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

organon pharma pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; povidone - adults (greater than or equal to 18 years) primary hypercholesterolaemia: - zient 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): - zient, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis). homozygous sitosterolaemia (phytosterolaemia): - zient is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,,prevention of cardiovascular disease zient 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 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): - zient 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): -zient 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)

organon pharma pty ltd - rosuvastatin calcium, quantity: 10.396 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium stearylfumarate; purified talc; macrogol 6000; lactose; colloidal anhydrous silica; maize starch; mannitol; hypromellose; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: rosuzet composite pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe. homozygous familial hypercholesterolaemia (hofh): rosuzet composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - rosuvastatin calcium, quantity: 5.198 mg - tablet, film coated - excipient ingredients: hypromellose; sodium stearylfumarate; macrogol 6000; mannitol; maize starch; lactose; microcrystalline cellulose; purified talc; colloidal anhydrous silica; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: ezalo composite pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh): ezalo composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - rosuvastatin calcium, quantity: 20.791 mg - tablet, film coated - excipient ingredients: maize starch; colloidal anhydrous silica; lactose; mannitol; purified talc; sodium stearylfumarate; macrogol 6000; microcrystalline cellulose; hypromellose; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: rosuzet composite pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe. homozygous familial hypercholesterolaemia (hofh): rosuzet composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - rosuvastatin calcium, quantity: 20.791 mg - tablet, film coated - excipient ingredients: maize starch; colloidal anhydrous silica; macrogol 6000; microcrystalline cellulose; lactose; sodium stearylfumarate; purified talc; hypromellose; mannitol; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: ezalo composite pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh): ezalo composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - rosuvastatin calcium, quantity: 5.198 mg - tablet, film coated - excipient ingredients: mannitol; purified talc; macrogol 6000; lactose; hypromellose; microcrystalline cellulose; maize starch; colloidal anhydrous silica; sodium stearylfumarate; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: rosuzet composite pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe. homozygous familial hypercholesterolaemia (hofh): rosuzet composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - rosuvastatin calcium, quantity: 10.396 mg - tablet, film coated - excipient ingredients: hypromellose; sodium stearylfumarate; lactose; colloidal anhydrous silica; purified talc; maize starch; macrogol 6000; mannitol; microcrystalline cellulose; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: ezalo composite pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh): ezalo composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - rosuvastatin calcium, quantity: 41.583 mg - tablet, film coated - excipient ingredients: lactose; microcrystalline cellulose; purified talc; hypromellose; colloidal anhydrous silica; maize starch; mannitol; macrogol 6000; sodium stearylfumarate; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: ezalo composite pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh): ezalo composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - rosuvastatin calcium, quantity: 41.583 mg - tablet, film coated - excipient ingredients: macrogol 6000; hypromellose; mannitol; sodium stearylfumarate; maize starch; colloidal anhydrous silica; lactose; microcrystalline cellulose; purified talc; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red - primary hypercholesterolaemia: rosuzet composite pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe. homozygous familial hypercholesterolaemia (hofh): rosuzet composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: povidone; magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; lactose monohydrate - adults ( greater than or equal to 18 years) primary hypercholesterolaemia ezetrol 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) ezetrol, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia) ezetrol is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease ezetrol, 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 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) ezetrol 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) ezetrol 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).