bempedoic acid / ezetimibe
Table of contents
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.
Nustendi : EPAR - Medicine overview (PDF/118.99 KB)
First published: 24/04/2020
Nustendi : EPAR - Risk-management-plan summary (PDF/85.15 KB)
First published: 24/04/2020
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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.
Daiichi Sankyo Europe GmbH
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19/04/2022 Nustendi - EMEA/H/C/004959 - IB/0026
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Lipid modifying agents
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