New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 5mg;   - film coated tablet - 5 mg - active: simvastatin 5mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow 20a52229 starch - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 80mg;   - film coated tablet - 80 mg - active: simvastatin 80mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate starch, pregelatinised (starch 1500) lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 20a54211 - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

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

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

medis pharma pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: iron oxide red; lactose monohydrate; croscarmellose sodium; iron oxide yellow; hypromellose; magnesium stearate; citric acid; iron oxide black; microcrystalline cellulose; butylated hydroxyanisole; propyl gallate; ascorbic acid - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-gx 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 ezetimibe/simvastatin-gx 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-gx 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-gx 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-gx 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)

medis pharma pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: iron oxide yellow; lactose monohydrate; croscarmellose sodium; iron oxide black; iron oxide red; ascorbic acid; microcrystalline cellulose; magnesium stearate; citric acid; propyl gallate; hypromellose; butylated hydroxyanisole - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-gx 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 ezetimibe/simvastatin-gx 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-gx 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-gx 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-gx 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)

medis pharma pty ltd - simvastatin, quantity: 80 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: ascorbic acid; hypromellose; citric acid; magnesium stearate; iron oxide yellow; propyl gallate; croscarmellose sodium; iron oxide black; lactose monohydrate; butylated hydroxyanisole; iron oxide red; microcrystalline cellulose - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-as 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 ezetimibe/simvastatin-as 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-as 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-as 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-as is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

United States - English - NLM (National Library of Medicine)

qpharma inc - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 20 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with coronary heart disease (chd) or at high risk of chd, simvastatin tablets can be started simultaneously with diet. in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets are indicated to: simvastatin tablets are indicated to: simvastatin tablets are indicated as an adjunct to diet to reduce total-c, ldl-c, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with hefh, if after an adequate trial of diet thera

United States - English - NLM (National Library of Medicine)

qpharma inc - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 40 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with coronary heart disease (chd) or at high risk of chd, simvastatin tablets can be started simultaneously with diet. in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets are indicated to: simvastatin tablets are indicated to: simvastatin tablets are indicated as an adjunct to diet to reduce total-c, ldl-c, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with hefh, if after an adequate trial of diet thera

United States - English - NLM (National Library of Medicine)

rebel distributors corp - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 5 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with coronary heart disease (chd) or at high risk of chd, simvastatin can be started simultaneously with diet. 1.1 reductions in risk of chd mortality and cardiovascular events in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets, usp are indicated to: - reduce the risk of total mortality by reducing chd deaths. - reduce the risk of non-fatal myocardial infarction and stroke. - reduce the need for coronary and non-coronary revascularization procedures. 1.2 hyperlipid

United States - English - NLM (National Library of Medicine)

cardinal health 107, llc - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 20 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with coronary heart disease (chd) or at high risk of chd, simvastatin tablets usp can be started simultaneously with diet. in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets usp are indicated to: simvastatin tablets usp are indicated to: simvastatin tablets usp are indicated as an adjunct to diet to reduce total-c, ldl-c, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with hefh, if after an adequate tri