🇪🇺 Direct Oral Anticoagulants in European Union

EMA authorised Direct Oral Anticoagulants on 19 April 2017

Marketing authorisations

EMA — authorised 19 April 2017

  • Application: EMEA/H/C/004339
  • Marketing authorisation holder: Berlin-Chemie AG
  • Local brand name: Roteas
  • 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.
  • Status: approved

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EMA — authorised 16 November 2020

  • Application: EMEA/H/C/005279
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Rivaroxaban Accord
  • Indication: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients). Adults Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk
  • Status: approved

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EMA — authorised 12 November 2021

  • Application: EMEA/H/C/005600
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Rivaroxaban Viatris (previously Rivaroxaban Mylan)
  • Indication: Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.  Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.  ------ Prevention of venous thromboembolism (VTE) in adult pa
  • Status: approved

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EMA — authorised 21 November 2025

  • Application: EMEA/H/C/006643
  • Marketing authorisation holder: Koanaa Healthcare GmbH
  • Local brand name: Rivaroxaban Koanaa
  • Indication: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or kneereplacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)
  • Status: approved

The European Medicines Agency (EMA) approved Rivaroxaban Koanaa, a Direct Oral Anticoagulant, on 21 November 2025. The medication is indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. It is also approved for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the prevention of recurrent DVT and PE in adults.

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Direct Oral Anticoagulants in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Direct Oral Anticoagulants approved in European Union?

Yes. EMA authorised it on 19 April 2017; EMA authorised it on 16 November 2020; EMA authorised it on 12 November 2021.

Who is the marketing authorisation holder for Direct Oral Anticoagulants in European Union?

Berlin-Chemie AG holds the EU marketing authorisation.