Malta - English - Medicines Authority

viatris hellas ltd 253-255, mesogion avenue, 154 51 neo psychiko, athens,, greece - atorvastatin - film-coated tablet - atorvastatin 10 mg - lipid modifying agents

Malta - English - Medicines Authority

viatris hellas ltd 253-255, mesogion avenue, 154 51 neo psychiko, athens,, greece - amlodipine besilate, atorvastatin calcium, trihydrate - film-coated tablet - atorvastatin calcium trihydrate 10 mg amlodipine besilate 5 mg - lipid modifying agents

Malta - English - Medicines Authority

viatris hellas ltd 253-255, mesogion avenue, 154 51 neo psychiko, athens,, greece - amlodipine besilate, atorvastatin calcium, trihydrate - film-coated tablet - amlodipine besilate 10 mg atorvastatin calcium trihydrate 10 mg - lipid modifying agents

Malta - English - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - film-coated tablet - atorvastatin 10 mg - lipid modifying agents

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

sandoz pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: hypromellose; lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose - adults (? 18 years),primary hypercholesterolaemia,ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),ezetimibe, is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in risk of cardiovascular events following at least one year therapy (see section 5.1 pharmacodynamic properties, clinical trials),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 co-administered with simvastatin (doses up to 40 mg) is indicated as an 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 co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

New Zealand - English - 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.

Israel - English - Ministry of Health

novartis israel ltd - ezetimibe - tablets - ezetimibe 10 mg - ezetimibe - primary hypercholesterolemia: ezetimibe sandoz administered with an hmg-coa reductase inhibitor (statin) or alone are indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. homozygous familial hypercholesterolemia (hofh): ezetimibe sandoz administered with a statin are indicated for use in patients with hofh.patients may also receive adjunctive treatments (e.g. ldl apheresis).homozygous sitosterolemia (phytosterolemia): ezetimibe sandoz are indicated for use in patients with homozygous familial sitosterolemia.

Israel - English - Ministry of Health

abic marketing ltd, israel - ezetimibe - tablets - ezetimibe 10 mg - ezetimibe - - primary hypercholesterolemia: ezetimibe teva administered with an hmg-coa reductase inhibitor (statin) or alone are indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. - homozygous familial hypercholesterolemia (hofh): ezetimibe teva administered with a statin are indicated for use in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).- homozygous sitosterolemia (phytosterolemia): ezetimibe teva is indicated for use in patients with homozygous familial sitosterolemia

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

lupin australia pty limited - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: crospovidone; colloidal anhydrous silica; lactose monohydrate; stearic acid; sodium lauryl sulfate; povidone - adults (greater than or equal to 18 years),primary hypercholesterolaemia,ezetimibe gh administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),ezetimibe gh, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia) ezetimibe gh is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. prevention of cardiovascular disease,ezetimibe gh is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) 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).,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 gh co-administered with simvastatin (doses up to 40 mg) is indicated as an 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 gh co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - simvastatin - oral tablet - 10mg