Rivaroxaban Viatris (previously Rivaroxaban Mylan) (rivaroxaban)
- Region
- 🇪🇺 EU
- Active substance
- rivaroxaban
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
- CHMP opinion
- Thu 16 Sep 2021
- EU approval
- Fri 12 Nov 2021
- Designations
- Generic
- Application
- EMEA/H/C/005600
- ATC
- B01AF01
- Official record
- www.ema.europa.eu
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 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. 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. 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. 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Svariya (previously Rivaroxaban Koanaa) Authorised · PGF Pharma International d.o.o.
- 🇪🇺 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.