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

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 86.8 mg (equivalent: atorvastatin, qty 80 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; povidone; hyprolose; silicon dioxide; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 (see clinical trials). primary hypercholesterolaemia atozet 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 atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in 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 - atorvastatin calcium trihydrate, quantity: 10.9 mg (equivalent: atorvastatin, qty 10 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: hyprolose; povidone; microcrystalline cellulose; magnesium stearate; silicon dioxide; lactose monohydrate; croscarmellose sodium; calcium carbonate; sodium lauryl sulfate; polysorbate 80; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 (see clinical trials).,primary hypercholesterolaemia atozet 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 atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe,homozygous familial hypercholesterolaemia (hofh) atozet is indicated in 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; atorvastatin calcium trihydrate, quantity: 43.4 mg (equivalent: atorvastatin, qty 40 mg) - tablet, multilayer - excipient ingredients: hyprolose; lactose monohydrate; croscarmellose sodium; silicon dioxide; magnesium stearate; microcrystalline cellulose; povidone; polysorbate 80; sodium lauryl sulfate; calcium carbonate; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 (see clinical trials). primary hypercholesterolaemia atozet 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 atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in 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 - atorvastatin calcium trihydrate, quantity: 21.7 mg (equivalent: atorvastatin, qty 20 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; sodium lauryl sulfate; silicon dioxide; povidone; magnesium stearate; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 (see clinical trials). primary hypercholesterolaemia atozet 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 atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - ezetimibe; atorvastatin calcium trihydrate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - ezetimibe; atorvastatin calcium trihydrate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - ezetimibe; atorvastatin calcium trihydrate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - ezetimibe; atorvastatin calcium trihydrate -

Malta - English - Medicines Authority

merck sharp & dohme limited - atorvastatin; ezetimibe - film-coated tablet - atorvastatin 10 mg; ezetimibe 10 mg - lipid modifying agents

Malta - English - Medicines Authority

merck sharp & dohme limited - atorvastatin; ezetimibe - film-coated tablet - atorvastatin 20 mg; ezetimibe 10 mg - lipid modifying agents