Evkeeza

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evinacumab

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

Overview

Evkeeza is a medicine used together with low-fat diet and other medicines to reduce levels of cholesterol in the blood. It is used in adults and adolescents aged 12 years and older with homozygous familial hypercholesterolaemia. This is an inherited disease that increases the levels of low-density lipoprotein cholesterol (LDL cholesterol or ‘bad cholesterol’) in the blood, which is a known risk factor for cardiovascular disease. 

Evkeeza contains the active substance evinacumab.

This EPAR was last updated on 12/10/2022

Authorisation details

Product details
Name
Evkeeza
Agency product number
EMEA/H/C/005449
Active substance
Evinacumab
International non-proprietary name (INN) or common name
evinacumab
Therapeutic area (MeSH)
Hypercholesterolemia
Anatomical therapeutic chemical (ATC) code
C10AX
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.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Ultragenyx Germany GmbH
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
17/06/2021
Contact address

Rahel-Hirsch-Str. 10
10557 Berlin
Germany

Product information

12/10/2022 Evkeeza - EMEA/H/C/005449 - IAIN/0006/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Lipid modifying agents

Therapeutic indication

Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).

Assessment history

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