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EMA Product

Vazkepa

Product approved by European Medicines Agency (EU)

Basic Information

Vazkepa

Regulatory Information

EMEA/H/C/005398

Authorised

March 26, 2021

January 28, 2021

7

August 1, 2024

Company Information

Ireland

88 Harcourt Street Dublin 2 D02DK18

AMARIN PHARMACEUTICALS IRELAND LIMITED

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Overview Summary

Vazkepa is a medicine for reducing the risk of cardiovascular events such as heart attack, stroke and other problems caused by blocked blood circulation. It is for use as add-on treatment in adults being treated with a statin medicine who have high levels of triglycerides (a type of fat) in their blood. Vazkepa is to be used in patients either with a cardiovascular disease (a condition that affects the heart or circulation) or with diabetes and another condition that increases the risk of cardiovascular events. Vazkepa contains the active substance icosapent ethyl.

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