United Kingdom - English - myHealthbox

glenmark pharmaceuticals europe limited - ezetimibe - tablets - 10mg - other lipid modifying agents - primary hypercholesterolaemia homozygous familial hypercholesterolaemia (hofh) homozygous sitosterolaemia (phytosterolaemia)

Ireland - English - HPRA (Health Products Regulatory Authority)

glenmark pharmaceuticals europe limited - ezetimibe - tablet - 10 milligram(s) - other lipid modifying agents; ezetimibe

Canada - English - Health Canada

glenmark pharmaceuticals canada inc. - ezetimibe - tablet - 10mg - ezetimibe 10mg - cholesterol absorption inhibitors

Singapore - English - HSA (Health Sciences Authority)

glenmark pharmaceuticals singapore pte. ltd. - ezetimibe - tablet - ezetimibe 10 mg

United States - English - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - ezetimibe tablets are indicated: when ezetimibe tablet is used in combination with a statin, fenofibrate, or other ldl-c lowering therapies, refer to the prescribing information of these products for information on the safe and effective use. risk summary there are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human exposure at the mrhd, based on auc (see data) . ezetimibe should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when ezetimibe is administered with a statin, refer to the prescribing information for the statin. the estimated background risk of major birth defects and miscarriage for the indic

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

glenmark pharmaceuticals europe ltd - ezetimibe - oral tablet - 10mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glenmark pharmaceuticals (malaysia) sdn. bhd. - ezetimibe -

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.

United States - English - NLM (National Library of Medicine)

sandoz inc - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - ezetimibe is indicated: when ezetimibe is used in combination with a statin, fenofibrate, or other ldl-c lowering therapies, refer to the prescribing information of these products for information on the safe and effective use. ezetimibe is contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe. hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [see adverse reactions (6.2)] . when used in combination with a statin, fenofibrate, or other ldl-c lowering therapy, ezetimibe is contraindicated in patients for whom a statin, fenofibrate, or other ldl-c lowering therapy are contraindicated. refer to the prescribing information of these products for a list of their contraindications [see warnings and precautions (5.1)] . risk summary there are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in anim