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

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

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

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

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

sandoz sa-nv - ezetimibe 10 mg; simvastatin 10 mg - tablet - 10 mg - 10 mg - ezetimibe 10 mg; simvastatin 10 mg - simvastatin and ezetimibe

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

impax generics - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24), simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - ezetimibe 10 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. ezetimibe and simvastatin tablets are indicated 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 patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. ezetimibe and simvastatin tablets are indicated for the reduction of elevated total-c and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments

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

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

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

pharmacor pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; lactose monohydrate; citric acid monohydrate; propyl gallate; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; butylated hydroxyanisole; hypromellose - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets 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.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets 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 and simvastatin tablets 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 and simvastatin tablets 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 and simvastatin tablets 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)

pharmacor pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; croscarmellose sodium; citric acid monohydrate; butylated hydroxyanisole; magnesium stearate; hypromellose; microcrystalline cellulose; propyl gallate; sodium lauryl sulfate - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets 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.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets 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 and simvastatin tablets 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 and simvastatin tablets 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 and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

aurobindo sa-nv - ezetimibe 10 mg; simvastatin 10 mg - tablet - 10 mg - 10 mg - ezetimibe 10 mg; simvastatin 10 mg - simvastatin and ezetimibe

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