Leqvio
inclisiran
Table of contents
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.
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List item
Leqvio : EPAR - Medicine overview (PDF/135.67 KB)
First published: 06/01/2021
EMA/561767/2020 -
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List item
Leqvio : EPAR - Risk-management-plan summary (PDF/56.99 KB)
First published: 06/01/2021
Authorisation details
Product details | |
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Name |
Leqvio
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Agency product number |
EMEA/H/C/005333
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Active substance |
inclisiran
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International non-proprietary name (INN) or common name |
inclisiran
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
C10AX
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Additional 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 | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Date of issue of marketing authorisation valid throughout the European Union |
09/12/2020
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Contact address |
Product information
09/12/2020 Leqvio - EMEA/H/C/005333 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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
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.