Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - perindopril tert-butylamine - tablets - 4 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

glenmark pharmaceuticals europe limited - perindopril tert-butylamine indapamide - tablets - 2/0.625 mg/mg

Ireland - English - HPRA (Health Products Regulatory Authority)

glenmark pharmaceuticals europe limited - perindopril tert-butylamine indapamide - tablets - 4/1.25 mg/mg

Ireland - English - HPRA (Health Products Regulatory Authority)

les laboratoires servier - perindopril tert-butylamine, indapamide - tablets - 8/2.5 mg/mg - ace inhibitors and diuretics

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

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,zeklen 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,zeklen 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),zeklen 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),zeklen 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),zeklen 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 - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet, uncoated - excipient ingredients: magnesium stearate; butylated hydroxyanisole; lactose monohydrate; hypromellose; microcrystalline cellulose; croscarmellose sodium; propyl gallate; citric acid monohydrate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,zeklen 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,zeklen 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),zeklen 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),zeklen 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),zeklen 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 - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: magnesium stearate; butylated hydroxyanisole; citric acid monohydrate; microcrystalline cellulose; croscarmellose sodium; propyl gallate; lactose monohydrate; hypromellose - adults (greater than or equal to 18 years),prevention of cardiovascular disease,zeklen 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,zeklen 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),zeklen 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),zeklen 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),zeklen 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 - 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,zeklen 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,zeklen 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),zeklen 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),zeklen 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),zeklen 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)

amneal pharma australia pty ltd - simvastatin, quantity: 5 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; butylated hydroxyanisole; lactose monohydrate; citric acid monohydrate; ascorbic acid; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. 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)

sandoz pty ltd - simvastatin, quantity: 40 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; citric acid monohydrate; lactose monohydrate; purified talc; ascorbic acid; hypromellose; pregelatinised maize starch; butylated hydroxyanisole; titanium dioxide; iron oxide red; magnesium stearate - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.