Svariya (previously Rivaroxaban Koanaa) (rivaroxaban)
- Region
- 🇪🇺 EU
- Active substance
- rivaroxaban
- Company
- PGF Pharma International d.o.o.
- Status
- Authorised
- Therapeutic area
- Venous Thromboembolism; Pulmonary Embolism; Venous Thrombosis; Stroke; Embolism
- CHMP opinion
- Thu 18 Sep 2025
- EU approval
- Fri 21 Nov 2025
- Designations
- Generic
- Application
- EMEA/H/C/006643
- ATC
- B01AF01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
Svariya (previously Rivaroxaban Koanaa) (rivaroxaban) approved in the EU
Marketing authorisation to PGF Pharma International d.o.o.; Generic · source
Same substance in other markets
- 🇪🇺 Rivaroxaban Viatris (previously Rivaroxaban Mylan) Authorised · Viatris Limited
- 🇪🇺 Xarelto Authorised · Bayer AG
- 🇪🇺 Rivaroxaban Accord Authorised · Accord Healthcare S.L.U.
- 🇺🇸 Yulzety Approved · Rosemont Pharms
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.