rivaroxaban
Xarelto · ATC code B01AF01
Brand names: Xarelto, Rivahib, Rivaroksaban Grindeks, Runaplax, Vixargio, Xaboplax, Elmardya, Rivadia, Rivarolto, Rivarox Viatris, Rivaxa, Rixacam, Thinban, Onaxan, Rivelto …
- Key facts
- Active substance
- rivaroxaban
- Drug class
- Direct Xa inhibitor
- ATC code
- B01AF01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Xarelto 2.5 mg film-coated tablets · Xarelto 10 mg film-coated tablets · Xarelto 15 mg film-coated tablets · Xarelto 20 mg film-coated tablets · Xarelto 15 mg film-coated tablets / Xarelto 20 mg film-coated tablets · Xarelto 1 mg/mL granules for oral suspension
- Marketing authorisation holder
- Bayer AG
- Information as of
- 2026-10-27
Key facts
Rivaroxaban (Xarelto) is a direct oral factor Xa inhibitor for prevention and treatment of venous thromboembolism, stroke prevention in atrial fibrillation and, at low dose, prevention of atherothrombotic events.
What it is used for
- Xarelto 2.5 mg with ASA (± clopidogrel/ticlopidine): atherothrombotic events after acute coronary syndrome with elevated biomarkers, and CAD or symptomatic PAD at high risk
- Xarelto 10 mg: VTE prevention after elective hip or knee replacement surgery
- Treatment of deep vein thrombosis and pulmonary embolism and prevention of recurrence in adults
- Prevention of stroke and systemic embolism in non-valvular atrial fibrillation with risk factors
- Children: treatment and prevention of recurrent VTE (details in full text)
Dosing
- Xarelto 2.5 mg (ACS, CAD/PAD): 2.5 mg twice daily together with 75 - 100 mg ASA daily
- Xarelto 10 mg after hip/knee replacement: 10 mg once daily, first dose 6 to 10 hours after surgery; 5 weeks (hip) or 2 weeks (knee)
- Atrial fibrillation: 20 mg once daily (also the maximum); creatinine clearance 15 - 49 ml/min: 15 mg once daily
- DVT/PE: 15 mg twice daily for the first three weeks, then 20 mg once daily; after at least 6 months, extended prevention with 10 mg or 20 mg once daily
- 15 mg and 20 mg tablets are taken with food
- Not recommended if creatinine clearance < 15 ml/min; paediatric weight-based dosing in the full text
Contraindications
- Hypersensitivity to the active substance or any excipient
- Active clinically significant bleeding; lesions with significant risk of major bleeding
- Hepatic disease with coagulopathy and bleeding risk (including cirrhosis Child Pugh B and C)
- Pregnancy and breast-feeding
Important warnings
- Increased bleeding risk; discontinue if severe haemorrhage occurs
- Epidural or spinal haematoma with neuraxial anaesthesia or puncture, possibly causing permanent paralysis
- Not recommended with prosthetic heart valves or in antiphospholipid syndrome with history of thrombosis
- Xarelto 2.5 mg: combination with prasugrel or ticagrelor not studied and not recommended
Side effects
- Bleeding, especially mucosal (epistaxis, gingival, gastrointestinal, genito-urinary)
- Anaemia; particularly with long-term treatment on top of antiplatelet therapy
Interactions
- Strong CYP3A4 and P-gp inhibitors (azole antimycotics such as ketoconazole, HIV protease inhibitors): not recommended
- Avoid dronedarone; other anticoagulants, NSAIDs and antiplatelets increase bleeding risk
- Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St. John's Wort) reduce levels; avoid unless closely observed
Pregnancy and breastfeeding
- Contraindicated during pregnancy and breast-feeding; women of child-bearing 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)
- Rivaroxaban Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/005279
- Rivaroxaban Viatris (previously Rivaroxaban Mylan) · genericViatris Limited · EMEA/H/C/005600
- Svariya (previously Rivaroxaban Koanaa) · genericPGF Pharma International d.o.o. · EMEA/H/C/006643
- XareltoBayer AG · EMEA/H/C/000944
Source: European Medicines Agency (EMA), product information
Austria
- RivahibG.L. Pharma Gmbh · 2 register entries
- Rivaroksaban GrindeksGrindeks · 1 register entry
- Rivaroxaban1a Pharma Gmbh, Stada Arzneimittel Gmbh, Ratiopharm Arzneimittel Vertriebs-Gmbh, Genericon Pharma Gesellschaft M.B.H., Bluefish Pharmaceuticals Ab, Glenmark Arzneimittel Gmbh, Grindeks, +pharma Arzneimittel Gmbh, Zentiva, K.S., Sandoz Gmbh, Reddy Holding Gmbh, Stada Arzneimittel Ges.M.B.H, G.L. Pharma Gmbh, Hcs Bvba · 19 register entries
- RunaplaxSandoz Gmbh · 1 register entry
- VixargioViatris Limited · 1 register entry
- XaboplaxSandoz Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- ElmardyaPharmathen S.A. · 1 register entry
- RivadiaTowa Pharmaceutical Europe S.L. · 1 register entry
- RivaroltoTad Pharma Gmbh · 1 register entry
- Rivarox ViatrisViatris Germany Gmbh · 1 register entry
- RivaroxabanIndoco Remedies Czech S.R.O., 089pharm Gmbh, 1 A Pharma Gmbh, 123 Acurae Pharma Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Aristo Pharma Gmbh (Art 57), Ascend Gmbh, Stadapharm Gmbh, Neuraxpharm Arzneimittel Gmbh, Aaa-Pharma Gmbh, Micro Labs Gmbh, Hec Pharm Gmbh, Medical Valley Invest Ab, Bluefish Pharmaceuticals Ab, Grindeks, Jubilant Pharmaceuticals Nv, Macleods Pharma España, S.L.U, Tillomed Pharma Gmbh, Alembic Pharmaceuticals Europe Ltd, Axcount Generika Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Torrent Pharma (Malta) Ltd, Vivanta Generics S.R.O, Zentiva Pharma Gmbh, Amarox Pharma Gmbh, Basics Gmbh, Acino Ag, Cipla Europe Nv, Elpen Pharmaceutical Co. Inc., Hexal Ag, Olimp Laboratories Sp. Z O.O., Olpha As, Abdi Farma Gmbh, Betapharm Arzneimittel Gmbh, Denk Pharma Gmbh & Co. Kg, Juta Pharma Gmbh, Abz-Pharma Gmbh, Apc Instytut Sp. Z O.O., Aliud Pharma Gmbh · 50 register entries
- RivaxaGlenmark Arzneimittel Gmbh · 1 register entry
- RixacamAdamed Pharma S.A. · 1 register entry
- ThinbanRatiopharm Gmbh · 2 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- OnaxanALİ RAİF İLAÇ SAN. A.Ş. · 4 register entries
- RiveltoATABAY KİMYA SAN. VE TİC. A.Ş. · 2 register entries
- RivoksarABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 7 register entries
- TromabanFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- VenmixSANTA FARMA İLAÇ SAN. A.Ş. · 3 register entries
- VenomiaSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- VorelbanVEM İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
- VoxabanNOBEL İLAÇ SAN. VE TİC. A.Ş. · 9 register entries
- XareltoBAYER TÜRK KİMYA SAN. LTD. ŞTİ. · 9 register entries
- XaroksARDİ FARMA İLAÇ PAZARLAMA TİC. LTD. ŞTİ. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Rivaroxaban
- Bulgaria
- Xaboplax Sandoz Pharmaceuticals D.D, Виатрикс, Воксабан, Дивлейз, Енкия, Кардатуксан, Ксабанел, Ксабоплакс, Ксанирва, Ксердоксо, Ксилтес, Полбаксан, Ривароксабан Гриндекс, Ривароксабан Полфарма, Ривароксабан Чайкафарма, Ривахиб, Рунаплакс, Руфиксало, Тинбан
- Croatia
- Aban, Bevimlar, Cloter, Dovequa, Ribas, Rivaroksaban Frontier, Rivaroksaban Grindeks, Rivaroksaban Stada, Rivaroksaban Teva, Rivaroksaban Zentiva, Robarox, Rocavys, Roxelana, Rufixalo, Runaplax, Vixargio, Xaboplax, Xerdoxo
- Cyprus
- Enkia, Naxat, Odelo, Rivarolto, Rivaroxaban Farmoz Genéricos, Rivaroxaban Pharmazac, Rivaroxaban Rafarm, Rivaroxaban Sandoz, Xabarem
- Czechia
- Axaltra, Bevimlar, Dovequa, Enkia, Kardatuxan, Razarxo, Ribas, Rinarot, Rivaroxaban Agmed, Rivaroxaban Auxpharma, Rivaroxaban Glenmark, Rivaroxaban Grindeks, Rivaroxaban Medreg, Rivaroxaban Msn, Rivaroxaban Olpha, Rivaroxaban Orion, Rivaroxaban Reddy, Rivaroxaban Sandoz, Rivaroxaban Stada, Rivaroxaban Teva, Rivaroxaban Zentiva, Runaplax, Xanirva, Xerdoxo, Xiltess
- Denmark
- Blomensy, Dovequa, Elmardya, Mirebax, Odelo, Rivaroxaban, Rivaxa
- Estonia
- Enkia, Kardatuxan, Razarxo, Rivaroxaban Alembic, Rivaroxaban Auxilia, Rivaroxaban G.L. Pharma, Rivaroxaban Grindeks, Rivaroxaban Olpha, Rivaroxaban Orion, Rivaroxaban Pharmazac, Rivaroxaban Siromed, Rivaroxaban Stada, Rivaroxaban Teva, Rivaroxaban Umedica, Rivaroxaban Viatris, Runaplax, Xaboplax, Xerdoxo
- Finland
- Blomensy, Dovequa, Rivaroksaban Grindeks, Rivaroxaban Avansor, Rivaroxaban Grindeks, Rivaroxaban Hexal, Rivaroxaban Krka, Rivaroxaban Orion, Rivaroxaban Ratiopharm, Rivaroxaban Sandoz, Rivaroxaban Stada, Rivaroxaban Tillomed, Rivaxa
- France
- Elmardya, Rivaroxaban Almus, Rivaroxaban Alter, Rivaroxaban Apc, Rivaroxaban Arrow, Rivaroxaban Benta, Rivaroxaban Bgr, Rivaroxaban Biogaran, Rivaroxaban Bluefish, Rivaroxaban Cipla, Rivaroxaban Cristers, Rivaroxaban Eg, Rivaroxaban Elc, Rivaroxaban Evolugen, Rivaroxaban Gnr, Rivaroxaban Grindeks, Rivaroxaban Hec Pharm, Rivaroxaban Huahai, Rivaroxaban Krka, Rivaroxaban Micro Labs, Rivaroxaban Olpha, Rivaroxaban Pharmaki, Rivaroxaban Reddy Pharma, Rivaroxaban Sandoz, Rivaroxaban Sun, Rivaroxaban Teva, Rivaroxaban Viatris Sante, Rivaroxaban Zentiva, Rivaroxaban Zydus
- Greece
- Blomensy, Cinstel, Elmardya, Enkia, Gremer, Obergan, Odelo, Raxivanol, Rexia, Rivarolto, Rivaroxaban Adelco, Rivaroxaban Ariti, Rivaroxaban Genepharm, Rivaroxaban Grindeks, Rivaroxaban Mediapharm, Rivaroxaban Pharmazac, Rivaroxaban Rafarm, Rivaroxaban Sandoz, Rivaroxaban Stada, Rivaroxaban Vocate, Rivaroxaban/Mediapharm, Rivaroxaban/Pharmazac, Rivatrop, Rixaven, Roxego, Runaplax, Xaboplax, Xanirva, Xareben, Xarivo, Xartil, Xavertia
- Hungary
- Dovequa, Evoxyr, Kardatuxan, Raxivanol, Razarxo, Rivaroxaban Grindeks, Rivaroxaban Kéri, Rivaroxaban Onkogen, Rivaroxaban Orion, Rivaroxaban Sandoz, Rivaroxaban Stada, Rivaroxaban Supremex, Rivaroxaban Teva, Rivaroxaban Zentiva, Rufixalo, Vixargio, Xerdoxo, Xiltess
- Iceland
- Agublon, Barsovi, Nabaxor, Rivaroksaban Grindeks, Rivaroksaban Wh, Rivaroxaban, Svariya, Xarelto
- Ireland
- Rivaroxaban Ascend, Rivaroxaban Azure, Rivaroxaban Bluefish, Rivaroxaban Clonmel, Rivaroxaban Grindeks, Rivaroxaban Krka, Rivaroxaban Msn, Rivaroxaban Pinewood, Rivaroxaban Renata Pharmaceuticals (Ireland), Rivaroxaban Rowa, Rivaroxaban Rowex, Rivaroxaban Teva, Rivaroxaban Tillomed
- Italy
- Ellebax, Indifaxa, Mirebax, Rivaroxaba Eg, Rivaroxaban Abdi, Rivaroxaban Alter, Rivaroxaban Aurobindo, Rivaroxaban Cipla, Rivaroxaban Doc, Rivaroxaban Dr. Reddy’s, Rivaroxaban Eg, Rivaroxaban Grindeks, Rivaroxaban Hcs, Rivaroxaban Huahai, Rivaroxaban Medical Valley, Rivaroxaban Mylan, Rivaroxaban Olpha, Rivaroxaban Pensa, Rivaroxaban Pharmacare, Rivaroxaban Sandoz, Rivaroxaban Sun, Rivaroxaban Tecnigen, Rivaroxaban Teva, Rivaroxaban Tillomed, Rivaroxaban Zentiva, Rixacam, Unoxir, Xolmia
- Latvia
- Kardatuxan, Mibrex, Polbaxan, Razarxo, Rivaroxaban Ascend, Rivaroxaban Auxilia, Rivaroxaban G.L. Pharma, Rivaroxaban Grindeks, Rivaroxaban Olpha, Rivaroxaban Orion, Rivaroxaban Polpharma, Rivaroxaban Siromed, Rivaroxaban Stada, Rivaroxaban Tad, Rivaroxaban Teva, Rivaroxaban Unifarma, Rixacam, Runaplax, Xaboplax, Xanirva, Xerdoxo, Xiltess
- Liechtenstein
- Rivaroxaban Accord, Rivaroxaban Viatris, Svariya, Xarelto
- Lithuania
- Enkia, Kardatuxan, Mibrex, Razarxo, Rivaroxaban Auxilia, Rivaroxaban Farmak, Rivaroxaban G.L. Pharma, Rivaroxaban Grindeks, Rivaroxaban Olpha, Rivaroxaban Orion, Rivaroxaban Pharmazac, Rivaroxaban Polpharma, Rivaroxaban Siromed, Rivaroxaban Stada, Rivaroxaban Teva, Runaplax, Xaboplax, Xanirva, Xerdoxo, Xiltess
- Luxembourg
- Rivaroxaban Eg, Rivaroxaban Grindeks, Rivaroxaban Micro Labs, Rivaroxaban Teva
- Malta
- Enkia, Naxat, Raxivanol, Rivanex, Rivarolto, Rivaroxaban Denk, Rivaroxaban Medichem, Rivaroxaban Pharos, Rivaroxaban Renata Pharmaceuticals (Ireland), Rivaroxaban Sandoz, Rivaroxaban Tillomed, Rivaroxaban Torrent, Xabarem
- Netherlands
- Blomensy, Rivaroksaban Grindeks, Rivaroxaban, Rivaxa, Runaplax, Tenarox, Xaboplax, Xartil, Xiltess
- Norway
- Dovequa, Rivaroxaban Accord, Rivaroxaban Bluefish, Rivaroxaban Cipla, Rivaroxaban Grindeks, Rivaroxaban Hexal, Rivaroxaban Indoco, Rivaroxaban Krka, Rivaroxaban Medical Valley, Rivaroxaban Orion, Rivaroxaban Sandoz, Rivaroxaban Stada, Rivaroxaban Teva, Rivaroxaban Tillomed, Rivaroxaban Viatris, Rivaroxaban Zentiva, Rivaxa, Svariya, Xarelto
- Poland
- Axaltra, Bevimlar, Diwleiz, Dovequa, Kardatuxan, Mibrex, Razarxo, Rivahib, Rivanoptim, Rivaroxaban Apc, Rivaroxaban Aurovitas, Rivaroxaban Bluefish, Rivaroxaban Farmak, Rivaroxaban G.L. Pharma, Rivaroxaban Lek-Am, Rivaroxaban Medical Valley, Rivaroxaban Medreg, Rivaroxaban Msn, Rivaroxaban Olimp, Rivaroxaban Olpha, Rivaroxaban Orion, Rivaroxaban Polpharma, Rivaroxaban Ranbaxy, Rivaroxaban Stada, Rivertaxo, Rixacam, Roxan, Runaplax, Rywaroksaban Tzf, Thinban, Vixargio, Xaboplax, Xanirva, Xerdoxo, Xiltess, Zarixa
- Portugal
- Closderive, Enkia, Epicar, Rivaroxaban Anova, Rivaroxabano
- Romania
- Enkia, Kardatuxan, Rivaroxaban, Runaplax, Xaboplax, Xanirva, Xerdoxo, Xiltess
- Slovakia
- Assubex, Bevimlar, Dovequa, Enkia, Kardatuxan, Razarxo, Ribas, Richter, Rivamed, Rivaroxaban Auxpharma, Rivaroxaban G.L. Pharma, Rivaroxaban Grindeks, Rivaroxaban Medreg, Rivaroxaban Msn, Rivaroxaban Olpha, Rivaroxaban Richter, Rivaroxaban Stada, Rivaroxaban Teva Gmbh, Rivaroxabán Sandoz, Rivaroxabán Teva, Rivaxa, Vixargio, Xaboplax Sandoz, Xanirva, Xerdoxo, Xiltess
- Slovenia
- Dovequa, Ribas, Rivaroksaban Grindeks, Rivaroksaban Teva, Rocavys, Rufixalo, Runaplax, Xaboplax, Xerdoxo
- Spain
- Blomensy, Elmardya, Enkia, Epicar, Plabelus, Rivaroxaban Alembic, Rivaroxaban Aurovitas, Rivaroxaban Dr. Reddys, Rivaroxaban Huahai, Rivaroxaban Krka, Rivaroxaban Olpha, Rivaroxaban Polpharma, Rivaroxaban Ptr Pharma, Rivaroxaban Sandoz, Rivaroxaban Tad, Rivaroxaban Tarbis, Rivaroxaban Vivanta, Rivaroxabán, Rivaxa, Rixacam, Rixavarte, Xariva
- Sweden
- Bevimlar, Blomensy, Dovequa, Rivaroxaban Aliud, Rivaroxaban Avansor, Rivaroxaban Bluefish, Rivaroxaban Grindeks, Rivaroxaban Hexal, Rivaroxaban Jubilant, Rivaroxaban Krka, Rivaroxaban Medical Valley, Rivaroxaban Orion, Rivaroxaban Reddy, Rivaroxaban Sandoz, Rivaroxaban Stada, Rivaroxaban Teva, Rivaroxaban Tillomed, Rivaroxaban Zentiva, Rivaxa
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- European Medicines Agency. Xarelto – 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/xarelto-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.