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

ezetimibe/simvastatin msd 10 mg/20 mg ezetimibe 10 mg and simvastatin 20 mg tablet blister pack

organon pharma pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; propyl gallate; hypromellose; citric acid monohydrate; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; butylated hydroxyanisole - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezetimibe/simvastatin msd is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin 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 section 5.1 pharmacodynamic properties, clinical trials).,primary hypercholesterolaemia,ezetimibe/simvastatin msd is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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/simvastatin msd is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,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/simvastatin msd is indicated as 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/simvastatin msd 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)

ezetimibe/simvastatin msd 10 mg/10 mg ezetimibe 10 mg and simvastatin 10 mg tablet blister pack

organon pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet, uncoated - excipient ingredients: hypromellose; citric acid monohydrate; lactose monohydrate; microcrystalline cellulose; propyl gallate; croscarmellose sodium; magnesium stearate; butylated hydroxyanisole - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezetimibe/simvastatin msd is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin 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 section 5.1 pharmacodynamic properties, clinical trials).,primary hypercholesterolaemia,ezetimibe/simvastatin msd is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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/simvastatin msd is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,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/simvastatin msd is indicated as 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/simvastatin msd is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).