Leqvio

RSS

inclisiran

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

Overview

Leqvio is a medicine used to reduce cholesterol in the blood. It is used in adults with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood). It should be used with a low-fat diet.

Leqvio is used in combination with a statin (a type of cholesterol-lowering medicine) when the maximum dose of the statin does not lower cholesterol levels enough. It can also be used in combination with other cholesterol-lowering medicines in patients who cannot take a statin.

Leqvio contains the active substance inclisiran.

This EPAR was last updated on 06/01/2021

Authorisation details

Product details
Name
Leqvio
Agency product number
EMEA/H/C/005333
Active substance
inclisiran
International non-proprietary name (INN) or common name
inclisiran
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
Novartis Europharm Limited
Date of issue of marketing authorisation valid throughout the European Union
09/12/2020
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

09/12/2020 Leqvio - EMEA/H/C/005333 -

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Pharmacotherapeutic group

Lipid modifying agents

Therapeutic indication

Leqvio 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.

Assessment history

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