🇪🇺 Evolocumab AI/pen in European Union

EMA authorised Evolocumab AI/pen on 17 July 2015

Marketing authorisation

Application: EMEA/H/C/003766
Marketing authorisation holder: Amgen Europe B.V.
Local brand name: Repatha
Indication: Hypercholesterolaemia and mixed dyslipidaemia Repatha 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 hypercholesterolaemia Repatha is indicated in adults and adolescents aged 1
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Evolocumab AI/pen approved in European Union?

Yes. EMA authorised it on 17 July 2015.

Who is the marketing authorisation holder for Evolocumab AI/pen in European Union?

Amgen Europe B.V. holds the EU marketing authorisation.