Praluent European Union - English - EMA (European Medicines Agency)

praluent

sanofi winthrop industrie - alirocumab - dyslipidemias - lipid modifying agents - primary hypercholesterolaemia and mixed dyslipidaemiapraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.established atherosclerotic cardiovascular disease praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.for study results with respect to effects on ldl-c, cardiovascular events and populations studied see section 5.1.

Repatha European Union - English - EMA (European Medicines Agency)

repatha

amgen europe b.v. - evolocumab - dyslipidemias; hypercholesterolemia - lipid modifying agents - hypercholesterolaemia and mixed dyslipidaemiarepatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.homozygous familial hypercholesterolaemiarepatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.established atherosclerotic cardiovascular diseaserepatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.for study results with respect to effects on ldl-c, cardiovascular events and populations studied see section 5.1.

Pelzont European Union - English - EMA (European Medicines Agency)

pelzont

merck sharp dohme ltd - laropiprant, nicotinic acid - dyslipidemias - lipid modifying agents - pelzont is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (ldl) cholesterol and triglycerides and low high-density-lipoprotein (hdl)cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).pelzont should be used in patients in combination with 3-hydroxy-3-methylglutaryl-coenzyme-a (hmg-coa)-reductase inhibitors (statins), when the cholesterol lowering effect of hmg-coa-reductase inhibitor monotherapy is inadequate. it can be used as monotherapy only in patients in whom hmg-coa-reductase inhibitors are considered inappropriate or not tolerated. diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with pelzont.

Tredaptive European Union - English - EMA (European Medicines Agency)

tredaptive

merck sharp dohme ltd. - laropiprant, nicotinic acid - dyslipidemias - lipid modifying agents - tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (ldl) cholesterol and triglycerides and low high-density-lipoprotein (hdl) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).tredaptive should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-a (hmg-coa)-reductase inhibitors (statins), when the cholesterol-lowering effect of hmg-coa-reductase inhibitor monotherapy is inadequate. it can be used as monotherapy only in patients in whom hmg-coa-reductase inhibitors are considered inappropriate or not tolerated. diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with tredaptive.

Trevaclyn European Union - English - EMA (European Medicines Agency)

trevaclyn

merck sharp dohme ltd - laropiprant, nicotinic acid - dyslipidemias - lipid modifying agents - trevaclyn is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (ldl) cholesterol and triglycerides and low high-density-lipoprotein (hdl) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).trevaclyn should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-a (hmg-coa)-reductase inhibitors (statins), when the cholesterol-lowering effect of hmg-coa-reductase-inhibitor monotherapy is inadequate. it can be used as monotherapy only in patients in whom hmg-coa-reductase inhibitors are considered inappropriate or not tolerated. diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with trevaclyn.

Nilemdo European Union - English - EMA (European Medicines Agency)

nilemdo

daiichi sankyo europe gmbh - bempedoic acid - hypercholesterolemia; dyslipidemias - lipid modifying agents - nilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl c goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.

Nustendi European Union - English - EMA (European Medicines Agency)

nustendi

daiichi sankyo europe gmbh - bempedoic acid, ezetimibe - hypercholesterolemia; dyslipidemias - lipid modifying agents - nustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin in addition to ezetimibealone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach ldl-c goals with ezetimibe alone,in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin

Leqvio European Union - English - EMA (European Medicines Agency)

leqvio

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - lipid modifying agents - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.