Repatha

RSS

evolocumab

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

Overview

An overview of Repatha and why it is authorised in the EU

This EPAR was last updated on 02/08/2018

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 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
8
Date of issue of marketing authorisation valid throughout the European Union
17/07/2015
Contact address
Minervum 7061
4817 ZK Breda
Netherlands

Product information

04/06/2018 Repatha - EMEA/H/C/003766 - IG/0946; II/0017

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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