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

torrent australasia pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 20 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; hypromellose; butylated hydroxyanisole; ferric oxide; ascorbic acid; citric acid monohydrate; lactose monohydrate; propyl gallate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,apo-ezetimine/simvastatin 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,apo-ezetimine/simvastatin 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),apo-ezetimine/simvastatin 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),apo-ezetimine/simvastatin 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),apo-ezetimine/simvastatin 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)

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)

organon pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 20 mg - tablet, uncoated - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; hypromellose; propyl gallate; croscarmellose sodium; butylated hydroxyanisole; citric acid monohydrate - adults (greater than or equal to 18 years) prevention of cardiovascular disease vytorin 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 clinical trials).,primary hypercholesterolaemia vytorin 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) vytorin 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) vytorin 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) vytorin 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)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 20 mg - tablet - excipient ingredients: lactose monohydrate; citric acid; propyl gallate; hypromellose; butylated hydroxyanisole; magnesium stearate; iron oxide black; croscarmellose sodium; iron oxide yellow; microcrystalline cellulose; ascorbic acid; iron oxide red - adults (?18 years),prevention of cardiovascular disease apo-ezetimibe/simvastatin 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 clinical trials).,primary hypercholesterolaemia apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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)

torrent australasia pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; propyl gallate; croscarmellose sodium; hypromellose; butylated hydroxyanisole; lactose monohydrate; ascorbic acid; ferric oxide; citric acid monohydrate; magnesium stearate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezetorin 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,ezetorin 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),ezetorin 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),ezetorin 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),ezetorin 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: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: citric acid monohydrate; propyl gallate; hypromellose; lactose monohydrate; butylated hydroxyanisole; ferric oxide; ascorbic acid; magnesium stearate; croscarmellose sodium; microcrystalline cellulose - 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).

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - ezetimibe 10 mg; simvastatin 20 mg - tablet - 10 mg - 20 mg - ezetimibe 10 mg; simvastatin 20 mg - simvastatin and ezetimibe

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - ezetimibe 10 mg; simvastatin 20 mg - tablet - 10 mg - 20 mg - ezetimibe 10 mg; simvastatin 20 mg - simvastatin and ezetimibe

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

krka d.d. novo mesto d.d. - simvastatin 20 mg; ezetimibe 10 mg - tablet - 10 mg - 20 mg - ezetimibe 10 mg; simvastatin 20 mg - simvastatin and ezetimibe

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - ezetimibe 10 mg; simvastatin 20 mg - tablet - 10 mg - 20 mg - ezetimibe 10 mg; simvastatin 20 mg - simvastatin and ezetimibe