Svariya (previously Rivaroxaban Koanaa)
Authorised
This medicine is authorised for use in the European Union
rivaroxaban
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Svariya is an anticoagulant medicine (a medicine that prevents blood clotting) used:
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 recurring in adults;
to prevent venous thromboembolism (VTE, the formation of blood clots in the veins) in adults who are undergoing surgery to replace a hip or knee;
to treat VTE and prevent VTE from recurring in children and adolescents aged less than 18 years;
to prevent stroke (caused by a blood clot in the brain) and systemic embolism (a blood clot in another organ) in adults with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
Svariya contains the active substance rivaroxaban and is a ‘generic medicine’. This means that Svariya contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Svariya is Xarelto. For more information on generic medicines, see the question-and-answer document here.
Svariya is available as a film to be placed on the tongue, where it will disperse rapidly. The dose and duration of treatment with Svariya depend on what it is being used for and the patient's risk of bleeding. For children, the dose and duration of treatment also depend on the patient’s age and weight.
The medicine can only be obtained with a prescription. For more information about using Svariya, see the package leaflet or contact your doctor or pharmacist.
The active substance in Svariya, rivaroxaban, is a factor Xa inhibitor. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is central to the process of blood clotting. By blocking factor Xa, the levels of thrombin decrease, which reduces the risk of blood clots forming in the veins and arteries and also treats existing clots.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Xarelto, and do not need to be repeated for R Svariya.
As for every medicine, the company provided studies on the quality of Svariya. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Because Svariya is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Svariya has been shown to have comparable quality and to be bioequivalent to Xarelto. Therefore, the Agency’s view was that, as for Xarelto, the benefits of Svariya outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Svariya have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Xarelto also apply to Svariya where appropriate.
As for all medicines, data on the use of Svariya are continuously monitored. Suspected side effects reported with Svariya are carefully evaluated and any necessary action taken to protect patients.
Svariya received a marketing authorisation valid throughout the EU on 21 November 2025.
Product information
Latest procedure affecting product information:VR/0000359284
29/07/2026
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).
Product details
- Name of medicine
- Svariya (previously Rivaroxaban Koanaa)
- Active substance
- rivaroxaban
- International non-proprietary name (INN) or common name
- rivaroxaban
- Therapeutic area (MeSH)
- Venous Thromboembolism
- Pulmonary Embolism
- Venous Thrombosis
- Stroke
- Embolism
- Anatomical therapeutic chemical (ATC) code
- B01AF01
Pharmacotherapeutic group
Antithrombotic agentsTherapeutic 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).
Prevention of atherothrombotic events
Adults prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. 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.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.
Adults prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. 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). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Svariya films should not be prescribed for patients with body weight less than 30 kg.
News on Svariya (previously Rivaroxaban Koanaa)
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