VAZKEPA®▼ (icosapent ethyl) is a prescription-only medicine

This means it can only be prescribed by a suitably qualified healthcare professional who can assess its suitability for individual patients.

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See yellowcard.mhra.gov.uk/ for how to report side effects.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk/.

By reporting side effects, you can help provide more information on the safety of this medicine.

Below you will find links to the Medicines and Healthcare products Regulatory Agency (MHRA) for the UK (excluding Northern Ireland), and to the European Medicines Agency for Northern Ireland. Through these websites you will find links to the European Public Assessment Report (EPAR) as well as the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for our licensed product VAZKEPA® (icosapent ethyl).

Please note that this information is not intended to replace the advice of a qualified healthcare professional.

Adverse events should be reported. Reporting forms and information can be at https://yellowcard.mhra.gov.uk/

Adverse events should be reported to Amarin Pharmaceuticals Ireland Limited:

Tel: 0800 0478 673 or e-mail: [email protected]

Information for Great Britain (England, Wales, Scotland)

Patient information leaflet (PIL): 
https://www.medicines.org.uk/emc/product/12964/pil

Summary of Product Characteristics (SmPC):
https://www.medicines.org.uk/emc/product/12964

Public Assessment Report (PAR): https://mhraproducts4853.blob.core.windows.net/docs/17a64d49a1e5aab9a165e09cbd7589449696ba54 


Information for Northern Ireland

Patient information leaflet (PIL):
https://www.ema.europa.eu/documents/product-information/vazkepa-epar-product-information_en.pdf

Summary of Product Characteristics (SmPC):
https://www.ema.europa.eu/documents/product-information/vazkepa-epar-product-information_en.pdf

Public Assessment Report (PAR):
https://www.ema.europa.eu/documents/assessment-report/vazkepa-epar-public-assessment-report_en.pdf

UK-NP-00209  03/2023