Human medicines European public assessment report (EPAR): Lixiana, edoxaban, Date of authorisation: 19/06/2015, Revision: 22, Status: Authorised

Lixiana RSS Authorised This medicine is authorised for use in the European Union edoxaban Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Lixiana is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults: to prevent stroke (caused by blood clots in the brain) and systemic embolism (blood clots in other organs) in patients with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart). It is used in patients who have one or more risk factors, such as high blood pressure, diabetes, heart failure, having had a stroke or being 75 years old or over; to treat deep-vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from re-occurring. Lixiana contains the active substance edoxaban. Expand section Collapse section How is Lixiana used? Lixiana is available as tablets and can only be obtained with a prescription. The usual dose is 60 mg once a day but doses may be adjusted for kidney function, low body weight or in those who are also taking certain medicines (known as P-gp inhibitors) that can interfere with the removal of edoxaban from the body. Dose adjustments may also need to be made in patients who are switched between Lixiana and other anticoagulant medicines. Treatment is continued while the benefit outweighs the risk of bleeding, which depends on the condition being treated and any existing risk factors. For more information about using Lixiana, see the package leaflet or contact your doctor or pharmacist. How does Lixiana work? The active substance in Lixiana, edoxaban, is a ‘factor Xa inhibitor’. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is essential for blood clotting. By blocking factor Xa, the medicine reduces the levels of thrombin in the blood, which helps treat clots and reduce the risk of them forming in the arteries and veins and leading to DVT, pulmonary embolism, stroke or other organ damage. What benefits of Lixiana have been shown in studies? Lixiana has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation. The effects were studied in one main study, which involved over 21,000 patients for an average of 2.5 years. The main measure of effectiveness was the rate of stroke or systemic embolism among the patients each year. A first systemic embolism or stroke occurred in around 1.2% of those given standard doses of Lixiana and 1.5% of those given warfarin respectively. When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 0.9% of patients given Lixiana and 1% of those given warfarin. There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal. In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Lixiana was also found to be as effective as warfarin, in a study involving over 8,200 patients. The main measure of effectiveness was the number of patients who had another episode of DVT or pulmonary embolism during the study period. Further episodes were seen in 130 of 4,118 patients given edoxaban (3.2%) and in 146 of 4,122 given warfarin (3.5%). What are the risks associated with Lixiana? The most common side effects with Lixiana (which may affect up to 1 in 10 people) are nose bleeds (epistaxis), blood in the urine (haematuria) and anaemia (low levels of red blood cells). Bleeding can occur at any site and can be severe or even fatal. For the full list of side effects of Lixiana, see the package leaflet. Lixiana must not be used in patients who are actively bleeding, have liver diseases that affect blood clotting, have severe uncontrolled high blood pressure or who have a condition putting them at significant risk of major bleeding. It must also not be used in pregnant or breastfeeding women or in patients also being treated with another anticoagulant. For the full list of restrictions, see the package leaflet. Why is Lixiana authorised in the EU? The European Medicines Agency decided that Lixiana’s benefits are greater than its risks and it can be authorised for use in the EU. The medicine has been shown to be at least as effective as warfarin in reducing stroke rates in patients with atrial fibrillation and in preventing further episodes of DVT or pulmonary embolism. With respect to safety, overall the risk of serious bleeding such as bleeding into the brain was reduced compared with warfarin, although there may be less difference where warfarin treatment is well managed. Although there was greater a risk of bleeding from the mucosa (tissues lining body cavities such as the nose, gut and vagina), the Agency considered that the risk could be managed with appropriate measures. What measures are being taken to ensure the safe and effective use of Lixiana? The company that markets Lixiana will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lixiana have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Lixiana are continuously monitored. Side effects reported with Lixiana are carefully evaluated and any necessary action taken to protect patients. Other information about Lixiana Lixiana received a marketing authorisation valid throughout the EU on 19 June 2015. Lixiana : EPAR - Medicine overview Reference Number: EMA/481992/2020 English (EN) (143.36 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View Other languages (22) български (BG) (169.23 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View español (ES) (142.57 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View čeština (CS) (167.69 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View dansk (DA) (151.2 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View Deutsch (DE) (146.6 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View eesti keel (ET) (140.48 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View ελληνικά (EL) (169.1 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View français (FR) (144.84 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View hrvatski (HR) (167.18 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View italiano (IT) (142.46 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View latviešu valoda (LV) (182.11 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View lietuvių kalba (LT) (166.38 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View magyar (HU) (166.89 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View Malti (MT) (179.13 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View Nederlands (NL) (142.76 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View polski (PL) (168.48 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View português (PT) (144.01 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View română (RO) (166.47 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View slovenčina (SK) (166.53 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View slovenščina (SL) (165.42 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View Suomi (FI) (140.25 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View svenska (SV) (141.4 KB - PDF) First published: 03/07/2015 Last updated: 16/09/2020 View Lixiana : EPAR - Risk management plan English (EN) (1.05 MB - PDF) First published: 04/10/2023 Last updated: 20/04/2026 View Product information Lixiana : EPAR - Product Information English (EN) (663.34 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View Other languages (24) български (BG) (1009.09 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View español (ES) (728.61 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View čeština (CS) (987.92 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View dansk (DA) (621.08 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View Deutsch (DE) (860.94 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View eesti keel (ET) (761.49 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View ελληνικά (EL) (981.66 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View français (FR) (914.11 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View hrvatski (HR) (639.07 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View íslenska (IS) (839.97 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View italiano (IT) (819 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View latviešu valoda (LV) (623.48 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View lietuvių kalba (LT) (713.91 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View magyar (HU) (630.69 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View Malti (MT) (1.04 MB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View Nederlands (NL) (814.3 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View norsk (NO) (641.96 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View polski (PL) (634.48 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View português (PT) (1.01 MB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View română (RO) (956.88 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View slovenčina (SK) (880.59 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View slovenščina (SL) (900.64 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View Suomi (FI) (835.66 KB - PDF) First published: 18/11/2015 Last updated: 16/10/2025 View svenska (SV) (699.55 KB - PDF) First published: 18/11/2015 Last updated: 22/10/2025 View Latest procedure affecting product information: VR/0000272457 24/07/2025 This medicine’s product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Lixiana : EPAR - All Authorised presentations English (EN) (12.5 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View Other languages (24) български (BG) (50.63 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View español (ES) (26.7 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View čeština (CS) (43.19 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View dansk (DA) (21.89 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View Deutsch (DE) (23.32 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View eesti keel (ET) (22.36 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View ελληνικά (EL) (62.95 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View français (FR) (23.36 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View hrvatski (HR) (46.8 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View íslenska (IS) (22.23 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View italiano (IT) (22.61 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View latviešu valoda (LV) (43.35 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View lietuvių kalba (LT) (47.13 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View magyar (HU) (47.76 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View Malti (MT) (44.95 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View Nederlands (NL) (24.3 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View norsk (NO) (22.31 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View polski (PL) (33.67 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View português (PT) (23.15 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View română (RO) (43.58 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View slovenčina (SK) (64.4 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View slovenščina (SL) (46.31 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View Suomi (FI) (22.33 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View svenska (SV) (21.93 KB - PDF) First published: 03/07/2015 Last updated: 14/01/2021 View Product details Name of medicine Lixiana Active substance edoxaban tosilate International non-proprietary name (INN) or common name edoxaban Therapeutic area (MeSH) Stroke Venous Thromboembolism Anatomical therapeutic chemical (ATC) code B01 Pharmacotherapeutic group Antithrombotic agents Therapeutic indication Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Authorisation details EMA product number EMEA/H/C/002629 Marketing authorisation holder Daiichi Sankyo Europe GmbH Zielstattstrasse 48 81379 Munich Germany Opinion adopted 23/04/2015 Marketing authorisation issued 19/06/2015 Revision 22 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Lixiana : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (157.78 KB - PDF) First published: 27/08/2025 Last updated: 20/04/2026 View Lixiana : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (160.51 KB - PDF) First published: 18/11/2015 Last updated: 27/08/2025 View Lixiana : EPAR - Paediatric investigation plan compliance statement Reference Number: EMA/10588/2024 English (EN) (96.01 KB - PDF) First published: 10/01/2024 View Lixiana-H-C-WS2409 : EPAR - Assessment report - Variation Reference Number: EMA/564306/2023 English (EN) (8.68 MB - PDF) First published: 10/01/2024 View Lixiana-H-C-PSUSA-00010387-202210 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/281620/2023 English (EN) (93.38 KB - PDF) First published: 04/10/2023 View Lixiana-H-C-002629-P46-012 : EPAR - Assessment Report Adopted Reference Number: EMA/571616/2022 English (EN) (518.17 KB - PDF) First published: 09/06/2022 View Lixiana-H-C-PSUSA-00010387-201710 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) Reference Number: EMA/CHMP/510786/2018 English (EN) (67.76 KB - PDF) First published: 03/08/2018 Last updated: 03/08/2018 View Lixiana-H-C-PSUSA-00010387-201610: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Adopted Reference Number: EMA/373380/2017 English (EN) (64.99 KB - PDF) First published: 20/07/2017 Last updated: 20/07/2017 View Initial marketing authorisation documents Lixiana : EPAR - Public assessment report Adopted Reference Number: EMA/321083/2015 English (EN) (17.87 MB - PDF) First published: 03/07/2015 Last updated: 03/07/2015 View CHMP summary of positive opinion for Lixiana Adopted Reference Number: EMA/CHMP/239353/2015 English (EN) (79.45 KB - PDF) First published: 24/04/2015 Last updated: 24/04/2015 View News on Lixiana Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015 24/04/2015 More information on Lixiana EMEA-000788-PIP02-11-M11 - paediatric investigation plan Venous Thromboembolism Treatment (VOLT) - post-authorisation study Topics Medicines This page was last updated on 20/04/2026 Share this page