European Union - English - EMA (European Medicines Agency)

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.

Canada - English - Health Canada

sanofi-aventis canada inc - alirocumab - solution - 75mg - alirocumab 75mg - proprotein convertase subtilisin kexin type 9 (pcsk9) inhibitors

Canada - English - Health Canada

sanofi-aventis canada inc - alirocumab - solution - 150mg - alirocumab 150mg - proprotein convertase subtilisin kexin type 9 (pcsk9) inhibitors

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

sanofi - alirocumab - solution for injection - 75mg/1ml

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

sanofi - alirocumab - solution for injection - 150mg/1ml

Israel - English - Ministry of Health

sanofi israel ltd - alirocumab - solution for injection - alirocumab 150 mg / 1 ml - alirocumab - 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 diseasepraluent 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.

Israel - English - Ministry of Health

sanofi israel ltd - alirocumab - solution for injection - alirocumab 75 mg / 1 ml - alirocumab - 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 diseasepraluent 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.

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - alirocumab - injection, solution - alirocumab 150mg

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - alirocumab - injection, solution - alirocumab 75mg

Canada - English - Health Canada

sanofi-aventis canada inc - alirocumab - solution - 75mg - alirocumab 75mg - proprotein convertase subtilisin kexin type 9 (pcsk9) inhibitors