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

teva pharma belgium sa-nv - ezetimibe 10 mg - tablet - 10 mg - ezetimibe 10 mg - ezetimibe

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

teva b.v. - ezetimibe 10 mg - tablet - 10 mg - ezetimibe 10 mg - ezetimibe

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

teva b.v. - ezetimibe 10 mg - tablet - 10 mg - ezetimibe 10 mg - ezetimibe

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

teva b.v. - ezetimibe 10 mg - tablet - 10 mg - ezetimibe 10 mg - ezetimibe

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

aristo pharma gmbh - ezetimibe 10 mg - tablet - 10 mg - ezetimibe 10 mg - ezetimibe

Ireland - English - HPRA (Health Products Regulatory Authority)

lexon pharmaceuticals (ireland) limited - ezetimibe - tablet - 10 milligram(s) - other lipid modifying agents; ezetimibe

Ireland - English - HPRA (Health Products Regulatory Authority)

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

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ezetimibe; simvastatin - tablet - 10 mg/40 milligram(s) - simvastatin and ezetimibe

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ezetimibe; simvastatin - tablet - 10 mg/80 milligram(s) - simvastatin and ezetimibe

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).