Repatha

RSS

evolocumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Repatha is a medicine for lowering levels of fats in the blood.

It is used to reduce blood fat levels in patients with primary hypercholesterolaemia (high blood cholesterol levels caused by a genetic abnormality), homozygous familial hypercholesterolaemia (a severe form of high blood cholesterol inherited from both parents) and mixed dyslipidaemia (abnormal levels of different fats, including cholesterol).

It is also used to reduce the risk of heart problems in patients with atherosclerosis (thickened arterial walls) who have had a heart attack, stroke or other problems of the circulatory system (atherosclerotic heart disease).

Repatha is used in combination with a statin or a statin and other fat-lowering medicines. Repatha can also be used without a statin in patients who cannot take statins. Some patients are required to be on a low fat diet.

Repatha contains the active substance evolocumab.

This EPAR was last updated on 17/10/2019

Authorisation details

Product details
Name
Repatha
Agency product number
EMEA/H/C/003766
Active substance
Evolocumab
International non-proprietary name (INN) or common name
evolocumab
Therapeutic area (MeSH)
  • Dyslipidemias
  • Hypercholesterolemia
Anatomical therapeutic chemical (ATC) code
C10AX13
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
17/07/2015
Contact address
Minervum 7061
4817 ZK Breda
Netherlands

Product information

12/09/2019 Repatha - EMEA/H/C/003766 - II/0033

Contents

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Pharmacotherapeutic group

LIPID MODIFYING AGENTS

Therapeutic 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 12 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.

For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.

Assessment history

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