Nilemdo

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bempedoic acid

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

Overview

Nilemdo is a medicine for lowering levels of cholesterol in the blood.

It is used in patients with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood). Patients taking the medicine are required to be on a low-fat diet.

Nilemdo is used in combination with a statin, with or without other fat-lowering medicines, in patients whose cholesterol levels are not lowered enough by the maximum dose of a statin. Nilemdo can also be used alone or in combination with other fat-lowering medicines in patients who cannot take statins.

Nilemdo contains the active substance bempedoic acid.

This EPAR was last updated on 24/06/2020

Authorisation details

Product details
Name
Nilemdo
Agency product number
EMEA/H/C/004958
Active substance
Bempedoic acid
International non-proprietary name (INN) or common name
bempedoic acid
Therapeutic area (MeSH)
  • Hypercholesterolemia
  • Dyslipidemias
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.

Publication details
Marketing-authorisation holder
Daiichi Sankyo Europe GmbH
Date of issue of marketing authorisation valid throughout the European Union
01/04/2020
Contact address

Zielstattstrasse 48
81379 Munich
Germany

Product information

12/06/2020 Nilemdo - EMEA/H/C/004958 - T/0001

Contents

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Pharmacotherapeutic group

Lipid modifying agents

Therapeutic indication

Nilemdo 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 (see sections 4.2, 4.3, and 4.4) or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.

Assessment history

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