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

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg; atorvastatin calcium trihydrate, quantity: 21.7 mg - tablet, film coated - excipient ingredients: calcium carbonate; colloidal anhydrous silica; hyprolose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; microcrystalline cellulose; polysorbate 80; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000; indigo carmine aluminium lake - amlodipine/atorvastatin-zp (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.,2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs,the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

medis pharma pty ltd - amlodipine besilate, quantity: 6.94 mg; atorvastatin calcium trihydrate, quantity: 21.7 mg - tablet, film coated - excipient ingredients: calcium carbonate; colloidal anhydrous silica; hyprolose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; microcrystalline cellulose; polysorbate 80; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - amlodipine/atorvastatin-zp (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.,2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs,the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ezetimibe; simvastatin - tablet - 10 mg/20 milligram(s) - simvastatin and ezetimibe

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg; simvastatin 10mg;   - tablet - 10mg/10mg - active: ezetimibe 10mg simvastatin 10mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate - primary hypercholesterolaemia zimybe is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), triglycerides (tg), and non high-density lipoprotein cholesterol (non-hdl-c), and to increase high-density lipoprotein cholesterol (hdl-c) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia in patients not adequately treated on a statin alone. homozygous familial hypercholesterolaemia (hofh) zimybe is indicated for the reduction of elevated total-c and ldl-c levels in adult and adolescent (10 to 17 years of age) patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg; simvastatin 40mg;   - tablet - 10mg/40mg - active: ezetimibe 10mg simvastatin 40mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate - primary hypercholesterolaemia zimybe is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), triglycerides (tg), and non high-density lipoprotein cholesterol (non-hdl-c), and to increase high-density lipoprotein cholesterol (hdl-c) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia in patients not adequately treated on a statin alone. homozygous familial hypercholesterolaemia (hofh) zimybe is indicated for the reduction of elevated total-c and ldl-c levels in adult and adolescent (10 to 17 years of age) patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg; simvastatin 80mg;   - tablet - 10mg/80mg - active: ezetimibe 10mg simvastatin 80mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate - primary hypercholesterolaemia zimybe is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), triglycerides (tg), and non high-density lipoprotein cholesterol (non-hdl-c), and to increase high-density lipoprotein cholesterol (hdl-c) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia in patients not adequately treated on a statin alone. homozygous familial hypercholesterolaemia (hofh) zimybe is indicated for the reduction of elevated total-c and ldl-c levels in adult and adolescent (10 to 17 years of age) patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

torrent australasia pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 40 mg - tablet - excipient ingredients: propyl gallate; ferric oxide; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; citric acid monohydrate; hypromellose; ascorbic acid; lactose monohydrate; butylated hydroxyanisole - adults (greater than or equal to 18 years),prevention of cardiovascular disease,simtorsi 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,simtorsi 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),simtorsi is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. 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),simtorsi is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),simtorsi is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

torrent australasia pty ltd - simvastatin, quantity: 80 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: butylated hydroxyanisole; microcrystalline cellulose; ascorbic acid; ferric oxide; citric acid monohydrate; hypromellose; magnesium stearate; lactose monohydrate; propyl gallate; croscarmellose sodium - adults (greater than or equal to 18 years),prevention of cardiovascular disease,simtorsi 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,simtorsi 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),simtorsi is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. 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),simtorsi is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),simtorsi is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

torrent australasia pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: croscarmellose sodium; ascorbic acid; microcrystalline cellulose; citric acid monohydrate; lactose monohydrate; butylated hydroxyanisole; propyl gallate; magnesium stearate; ferric oxide; hypromellose - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezsimva gh 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,ezsimva gh 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),ezsimva gh s is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. 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),ezsimva gh is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),ezsimva gh is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

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

torrent australasia pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: butylated hydroxyanisole; croscarmellose sodium; microcrystalline cellulose; ascorbic acid; lactose monohydrate; citric acid monohydrate; hypromellose; ferric oxide; propyl gallate; magnesium stearate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezsimva gh 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,ezsimva gh 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),ezsimva gh s is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. 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),ezsimva gh is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh 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),ezsimva gh is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).