Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

organon pharma (ireland) limited - ezetimibe; atorvastatin - film-coated tablet - 10 mg/10 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; atorvastatin and ezetimibe

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

medis pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: iron oxide yellow; lactose monohydrate; ascorbic acid; citric acid; iron oxide black; hypromellose; propyl gallate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; butylated hydroxyanisole; iron oxide red - 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).

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

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

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

zentiva k.s. - ezetimibe; atorvastatin - film-coated tablet - atorvastatin and ezetimibe

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

zentiva k.s. - ezetimibe; atorvastatin calcium trihydrate - film-coated tablet - atorvastatin and ezetimibe

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

zentiva k.s. - ezetimibe; atorvastatin calcium trihydrate - film-coated tablet - atorvastatin and ezetimibe

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

zentiva k.s. - ezetimibe; atorvastatin calcium trihydrate - film-coated tablet - atorvastatin and ezetimibe

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

accord healthcare limited - ezetimibe - tablet - 10 milligram(s) - other lipid modifying agents; ezetimibe

Kanada - Inggeris - Health Canada

pro doc limitee - ezetimibe - tablet - 10mg - ezetimibe 10mg - cholesterol absorption inhibitors

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ezetimibe - tablet - 10 milligram(s) - other lipid modifying agents; ezetimibe