Canada - English - Health Canada

mylan pharmaceuticals ulc - ezetimibe - tablet - 10mg - ezetimibe 10mg - cholesterol absorption inhibitors

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - ezetimibe; simvastatin - tablet - 10 mg/40 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe - reductase inhibitors in combination with other lipid modifying agents - it is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familiar and non-familiar) hypercholesterolaemia or mixed hyperlipidaemia, and in patient with hofh

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - ezetimibe; simvastatin - tablet - 10mg/20 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe - reductase inhibitors in combination with other lipid modifying agents - it is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familiar and non-familiar) hypercholesterolaemia or mixed hyperlipidaemia, and in patient with hofh

Ireland - English - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - rosuvastatin calcium; ezetimibe - film-coated tablet - 10/10 mg/mg - rosuvastatin and ezetimibe

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 10 mg ezetimibe 10 mg - lipid modifying agents

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - ezetimibe; simvastatin - tablet - 10mg/80 milligram(s) - hmg coa reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe - reductase inhibitors in combination with other lipid modifying agents - it is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familiar and non-familiar) hypercholesterolaemia or mixed hyperlipidaemia, and in patient with hofh

Ireland - English - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - rosuvastatin calcium; ezetimibe - film-coated tablet - 10/20 mg/mg - rosuvastatin and ezetimibe

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg; simvastatin 10mg;   - tablet - 10mg/10mg - active: ezetimibe 10mg simvastatin 10mg   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).

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg; simvastatin 20mg;   - tablet - 10mg/20mg - active: ezetimibe 10mg simvastatin 20mg   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).

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg; simvastatin 40mg;   - tablet - 10mg/40mg - active: ezetimibe 10mg simvastatin 40mg   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).