edoxaban
Lixiana, Roteas · ATC code B01AF03
Brand names: Lixiana, Roteas, Edoflusio, Gledohib, Hevagtu, Edoxtra
- Key facts
- Active substance
- edoxaban
- Drug class
- Direct Xa inhibitor
- ATC code
- B01AF03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Lixiana 15 mg film-coated tablets / Lixiana 30 mg film-coated tablets / Lixiana 60 mg film-coated tablets · Roteas 15 mg film-coated tablets / Roteas 30 mg film-coated tablets / Roteas 60 mg film-coated tablets
- Marketing authorisation holder
- Daiichi Sankyo Europe GmbH, Berlin-Chemie AG
- Information as of
- 2026-10-27
Key facts
Edoxaban is an oral direct factor Xa inhibitor used for stroke prevention in nonvalvular atrial fibrillation and to treat and prevent deep vein thrombosis and pulmonary embolism.
What it is used for
- Prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation and one or more risk factors
- Treatment of deep vein thrombosis and pulmonary embolism, and prevention of recurrence, in adults
Dosing
- Atrial fibrillation: 60 mg once daily, long term
- VTE: 60 mg once daily after at least 5 days of parenteral anticoagulant; duration individualised, at least 3 months for transient risk factors
- 30 mg once daily with CrCl 15 - 50 mL/min, body weight ≤ 60 kg, or concomitant ciclosporin, dronedarone, erythromycin or ketoconazole
- 15 mg only when switching from 30 mg to a vitamin K antagonist
- Switching from VKA: start when INR ≤ 2.5; a missed dose is taken immediately, never doubled
Contraindications
- Hypersensitivity; clinically significant active bleeding
- Hepatic disease with coagulopathy and clinically relevant bleeding risk
- Lesions with significant risk of major bleeding; uncontrolled severe hypertension
- Concomitant other anticoagulants (except when switching)
- Pregnancy and breast-feeding
Important warnings
- Increased risk of bleeding, including serious and fatal bleeding; discontinue if severe haemorrhage occurs
- Mucosal bleeding and anaemia more frequent than with VKA; haemoglobin testing may help
- Patients at increased bleeding risk carefully monitored
- Anticoagulant effect cannot be reliably monitored with standard tests
Side effects
- Most common: epistaxis, haematuria and anaemia
- Common: dizziness, headache
- Uncommon: intracranial haemorrhage, thrombocytopenia, hypersensitivity; rare anaphylactic reaction
Interactions
- P-gp inhibitors ciclosporin, dronedarone, erythromycin, ketoconazole: dose reduced to 30 mg
- Quinidine, verapamil, amiodarone: no dose reduction needed
- Other anticoagulants contraindicated (except when switching)
Pregnancy and breastfeeding
- Contraindicated in pregnancy and breast-feeding; women of childbearing potential should avoid becoming pregnant
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
Source: European Medicines Agency (EMA), product information
Austria
- EdoflusioSandoz Gmbh · 1 register entry
- Edoxaban1a Pharma Gmbh, G.L. Pharma Gmbh, Ratiopharm Arzneimittel Vertriebs-Gmbh, Genericon Pharma Gesellschaft M.B.H., Actavis Group Ptc Ehf., +pharma Arzneimittel Gmbh, Zentiva, K.S., Reddy Holding Gmbh, Stadapharm Gmbh, Hcs Bvba · 13 register entries
- GledohibG.L. Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Edoxaban1 A Pharma Gmbh, 123 Acurae Pharma Gmbh, Zentiva Pharma Gmbh, Cipla Europe Nv, Hexal Ag, Betapharm Arzneimittel Gmbh, Denk Pharma Gmbh & Co. Kg, Tad Pharma Gmbh · 8 register entries
- HevagtuAbdi Farma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- EdoxtraNOBEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- LixianaDAİİCHİ SANKYO İLAÇ TİC. LTD. ŞTİ. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 27 more European countries
- Belgium
- Edoxaban Hcs, Edoxaban Sandoz, Edoxaban Teva, Oblonela
- Bulgaria
- Edoflusio, Делианда, Едоксабан G.L. Pharma, Едоксабан Полфарма, Едоксабел, Ексаблок, Ендора, Каглуен, Кимбек, Прамадокс, Сетиапо, Софедокс
- Croatia
- Cagluen, Delianda, Ebozen, Edoksaban Accord, Edoksaban Galenika, Edoksaban Genericon, Edoksaban Olpha, Edoksaban Stada, Edoxaban Accord, Setiapo, Zorraten
- Czechia
- Delianda, Edoxaban +pharma, Edoxaban Sandoz, Edoxaban Stada, Edoxaban Tad, Edoxaban Teva, Edoxaban Viatris, Edoxaban Zentiva, Kymbek, Setiapo
- Denmark
- Arelzamio, Dijuga, Edoxaban "denk", Edoxaban Krka, Edoxaban Pharmapath, Edoxaban Sandoz, Edoxaban Teva, Edoxaban Zentiva, Hevagtu
- Estonia
- Delianda, Edoflusio, Edoxaban Accord, Edoxaban G.L. Pharma, Edoxaban Olpha, Edoxaban Stada, Edoxaban Tad, Edoxaban Teva, Edoxaban Zentiva
- Finland
- Edoxaban Avansor, Edoxaban Krka, Edoxaban Ratiopharm, Edoxaban Sandoz, Edoxaban Zentiva
- France
- Oblonela
- Greece
- Delianda, Edoxaban Pharmapath, Oblonela, Publicen
- Hungary
- Cagluen, Delianda, Edoxaban Accord, Edoxaban Galenika, Edoxaban Pharos, Edoxaban Sandoz, Edoxaban Stada, Edoxaban Tad, Edoxaban Teva, Edoxaban Tiefenbacher, Edoxaban Tosylate Monohydrate Viatris, Edoxaban Viatris, Edoxaban Zentiva, Edoxabán Doc, Kymbek, Zorraten
- Iceland
- Edoxaban Accord, Edoxaban Krka, Edoxaban Sandoz, Edoxaban Teva, Edoxaban Wh, Edoxaban Zentiva, Lixiana, Roteas
- Ireland
- Edoxaban Accord, Edoxaban Krka, Edoxaban Teva, Edoxaban Tosylate Monohydrate Rowex, Edoxaban Zentiva
- Italy
- Edoxaban Dr. Reddy’s, Edoxaban Hcs, Edoxaban Sandoz, Edoxaban Teva, Edoxaban Towa, Edoxaban Zentiva
- Latvia
- Delianda, Edoflusio, Edoxaban Accord, Edoxaban G.L. Pharma, Edoxaban Olpha, Edoxaban Polpharma, Edoxaban Stada, Edoxaban Tad, Edoxaban Teva, Edoxaban Tosylate Monohydrate Viatris, Edoxaban Zentiva, Kymbek
- Liechtenstein
- Lixiana, Roteas
- Lithuania
- Delianda, Edoflusio, Edoxaban Accord, Edoxaban G.L. Pharma, Edoxaban Olpha, Edoxaban Stada, Edoxaban Tad, Edoxaban Teva, Edoxaban Zentiva
- Luxembourg
- Oblonela
- Malta
- Dijuga, Edoxaban Clonmel, Edoxaban Doc, Edoxaban Pharos, Edoxaban Stada, Edoxaban Synthon, Ixbelor, Phexalin
- Netherlands
- Edoxaban Cipla, Edoxaban G.L. Pharma, Edoxaban Hcs, Edoxaban Reddy, Edoxaban Sandoz, Edoxaban Synthon, Edoxaban Teva, Edoxaban Zentiva, Gledohib
- Norway
- Edoxaban Krka, Edoxaban Sandoz, Edoxaban Teva, Edoxaban Zentiva, Lixiana, Roteas
- Poland
- Delianda, Edoflusio, Edoxaban +pharma, Edoxaban Tad, Exablok, Kymbek, Setiapo
- Portugal
- Edoxabano Bluepharma, Edoxabano Kern Pharma, Edoxabano Krka, Edoxabano Ratiopharm, Edoxabano Sandoz, Edoxabano Tad, Edoxabano Teva, Edoxabano Towa, Edoxabano Zentiva
- Romania
- Cagluen, Delianda, Edoflusio, Edoxaban Accord, Edoxaban Stada, Edoxaban Teva, Erjulizam, Kymbek, Setiapo
- Slovakia
- Delianda, Edoxaban Accord, Edoxaban Olpha, Edoxaban Sandoz, Edoxaban Tad, Edoxaban Teva, Edoxaban Tiefenbacher, Edoxaban Tosylate Monohydrate Viatris, Edoxabán Stada, Ixbelor, Kymbek, Setiapo
- Slovenia
- Delianda, Edoflusio, Edoksaban Accord, Edoksaban Galenika, Edoksaban Hcs, Edoksaban Krka, Edoksaban Tad
- Spain
- Edoxabán Almus, Edoxabán Cinfa, Edoxabán Combix, Edoxabán Kern Pharma, Edoxabán Normon, Edoxabán Sandoz, Edoxabán Stada, Edoxabán Tad, Edoxabán Teva
- Sweden
- Edoflusio, Edoxaban Avansor, Edoxaban Elpen, Edoxaban Hexal, Edoxaban Krka, Edoxaban Reddy, Edoxaban Sandoz, Edoxaban Teva, Edoxaban Zentiva, Erjulizam, Exablok, Fasemets, Nabaxo, Sinsferk
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- European Medicines Agency. Lixiana – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/lixiana-epar-product-information_en.pdf
- European Medicines Agency. Roteas – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/roteas-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC B01AF.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.