European Union - English - EMA (European Medicines Agency)

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.

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

amgen ltd - evolocumab - solution for injection - 140mg/1ml

Israel - English - Ministry of Health

amgen europe b.v. - evolocumab - solution for injection - evolocumab 140 mg/ml - evolocumab - hypercholesterolaemia and mixed dyslipidaemiarepatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, 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 hypercholesterolaemia repatha is indicated in adults and paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.established atherosclerotic cardiovascular disease repatha 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.

Singapore - English - HSA (Health Sciences Authority)

amgen biotechnology singapore pte ltd - evolocumab - injection, solution - evolocumab 140mg/ml

Singapore - English - HSA (Health Sciences Authority)

amgen biotechnology singapore pte ltd - evolocumab - injection, solution - evolocumab 140 mg/ml

Canada - English - Health Canada

amgen canada inc - evolocumab - solution - 140mg - evolocumab 140mg - proprotein convertase subtilisin kexin type 9 (pcsk9) inhibitors

Canada - English - Health Canada

amgen canada inc - evolocumab - solution - 120mg - evolocumab 120mg - proprotein convertase subtilisin kexin type 9 (pcsk9) inhibitors

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

amgen ltd - evolocumab - solution for injection - 140mg/1ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

amgen europe b.v. - evolocumab - solution for injection - 140 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

amgen europe b.v., netherlands - evolocumab - solution for injection - 140 mg/ml