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EMA Product

Leqvio

Product approved by European Medicines Agency (EU)

Basic Information

Leqvio

Regulatory Information

EMEA/H/C/005333

Authorised

December 9, 2020

October 15, 2020

8

November 28, 2024

Company Information

Ireland

Vista Building Elm Park Merrion Road Dublin 4

NOVARTIS EUROPHARM LIMITED

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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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