Repatha
evolocumab
Table of contents
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.
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List item
Repatha : EPAR - Summary for the public (PDF/81.24 KB)
First published: 03/08/2015
Last updated: 29/05/2018
EMA/352855/2015 -
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List item
Repatha : EPAR - Risk-management-plan summary (PDF/68.7 KB)
First published: 03/08/2015
Last updated: 12/10/2015
EMA/378892/2015
Authorisation details
Product details | |
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Name |
Repatha
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Agency product number |
EMEA/H/C/003766
|
Active substance |
Evolocumab
|
International non-proprietary name (INN) or common name |
evolocumab
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
C10AX13
|
Publication details | |
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Marketing-authorisation holder |
Amgen Europe B.V.
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Revision |
15
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Date of issue of marketing authorisation valid throughout the European Union |
17/07/2015
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Contact address |
Product information
29/10/2020 Repatha - EMEA/H/C/003766 - II/0043
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.