Ирландия - английски - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ezetimibe; simvastatin - tablet - 10 mg/20 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

Ирландия - английски - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ezetimibe; simvastatin - tablet - 10 mg/40 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

Ирландия - английски - HPRA (Health Products Regulatory Authority)

rowex ltd - ezetimibe; simvastatin - tablet - 10 mg/20 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

Ирландия - английски - HPRA (Health Products Regulatory Authority)

rowex ltd - ezetimibe; simvastatin - tablet - 10 mg/80 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

Ирландия - английски - HPRA (Health Products Regulatory Authority)

rowex ltd - ezetimibe; simvastatin - tablet - 10 mg/40 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

Австралия - английски - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - rosuvastatin calcium, quantity: 10.4 mg (equivalent: rosuvastatin, qty 10 mg) - tablet, film coated - excipient ingredients: light magnesium oxide; magnesium stearate; lactose monohydrate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; triacetin; iron oxide red - primary hypercholesterolaemia,ezecrest composite pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients:,? not appropriately controlled with rosuvastatin or ezetimibe alone; or ? already treated with rosuvastatin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),ezecrest composite pack is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - ezetimibe 10mg;   - tablet - 10 mg - active: ezetimibe 10mg   excipient: croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate - ezetimibe sandoz administered with an hmg-coa reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), and triglycerides (tg) and to increase high-density lipoprotein cholesterol (hdl-c) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.

Ирландия - английски - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - rosuvastatin calcium; ezetimibe - film-coated tablet - rosuvastatin and ezetimibe

Австралия - английски - 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).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet - excipient ingredients: propyl gallate; croscarmellose sodium; lactose monohydrate; citric acid monohydrate; magnesium stearate; microcrystalline cellulose; hypromellose; sodium lauryl sulfate; butylated hydroxyanisole - 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).