New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg; simvastatin 80mg;   - tablet - 10mg/80mg - active: ezetimibe 10mg simvastatin 80mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate - primary hypercholesterolaemia zimybe 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), triglycerides (tg), and non high-density lipoprotein cholesterol (non-hdl-c), 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 or mixed hyperlipidaemia in patients not adequately treated on a statin alone. homozygous familial hypercholesterolaemia (hofh) zimybe is indicated for the reduction of elevated total-c and ldl-c levels in adult and adolescent (10 to 17 years of age) patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - rosuvastatin, ezetimibe - film-coated tablet - rosuvastatin 20 mg ezetimibe 10 mg - lipid modifying agents

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg;   - tablet - 10 mg - active: ezetimibe 10mg   excipient: croscarmellose sodium crospovidone hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose purified water sodium laurilsulfate - 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.

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

viatris uk healthcare ltd - ezetimibe - oral tablet - 10mg

Ireland - English - HPRA (Health Products Regulatory Authority)

generics (uk) limited - ezetimibe - tablets - 10 milligram - ezetimibe

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

alphapharm pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; sodium lauryl sulfate; crospovidone; lactose monohydrate; croscarmellose sodium; hypromellose - 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).

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

alphapharm pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; lactose monohydrate; sodium lauryl sulfate; hypromellose; croscarmellose sodium; crospovidone - 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).

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - ezetimibe - tablet - 10 milligram(s) - other lipid modifying agents; ezetimibe

Canada - English - Health Canada

mylan pharmaceuticals ulc - atorvastatin (atorvastatin calcium) - tablet - 10mg - atorvastatin (atorvastatin calcium) 10mg - hmg-coa reductase inhibitors

Canada - English - Health Canada

mylan pharmaceuticals ulc - simvastatin - tablet - 10mg - simvastatin 10mg - hmg-coa reductase inhibitors