Nustendi

RSS

bempedoic acid / ezetimibe

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

Overview

Nustendi 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.

Nustendi contains the active substances bempedoic acid and ezetimibe.

Nustendi is used in combination with a statin in patients whose cholesterol levels are not lowered enough by the maximum dose of a statin taken together with ezetimibe. Nustendi can also be used alone in patients who cannot take statins and whose cholesterol levels are not lowered enough by ezetimibe. The medicine can be used to replace separate tablets of bempedoic acid and ezetimibe in patients already taking them.

This EPAR was last updated on 31/08/2020

Authorisation details

Product details
Name
Nustendi
Agency product number
EMEA/H/C/004959
Active substance
  • Bempedoic acid
  • Ezetimibe
International non-proprietary name (INN) or common name
  • bempedoic acid
  • ezetimibe
Therapeutic area (MeSH)
  • Hypercholesterolemia
  • Dyslipidemias
Anatomical therapeutic chemical (ATC) code
C10B
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
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
27/03/2020
Contact address

Zielstattstrasse 48
81379 Munich
Germany

Product information

17/07/2020 Nustendi - EMEA/H/C/004959 - IAIN/0004/G

Contents

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

Nustendi 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 in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
  • alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,
  • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin

Assessment history

How useful was this page?

Add your rating
Average
1 rating
1 rating