Rivaroxaban Mylan

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rivaroxaban

Authorised
This medicine is authorised for use in the European Union.

Overview

Rivaroxaban Mylan 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 re-occurring 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 re-occurring in children and adolescents aged less than 18 years weighing more than 30 kg;
  • to prevent stroke (caused by a clot in a blood vessel in the brain) and systemic embolism (a clot in other blood vessels) in adults with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart);
  • to prevent atherothrombotic events (such as heart attack, stroke or death from heart disease) in adults: 
    • after an acute coronary syndrome, when it is used with an antiplatelet medicine (which prevents the formation of blood clots). Acute coronary syndrome consists of conditions such as unstable angina (a severe type of chest pain) and heart attack;
    • at high risk of ischaemic events (problems caused by restricted blood supply) who have coronary artery disease (disease caused by obstructed blood supply to the heart muscle) or peripheral artery disease (disease caused by defective blood flow in the arteries). It is used with aspirin.

Rivaroxaban Mylan contains the active substance rivaroxaban and is a ‘generic medicine’. This means that Rivaroxaban Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Xarelto. For more information on generic medicines, see the question-and-answer document here.
 

This EPAR was last updated on 25/02/2022

Authorisation details

Product details
Name
Rivaroxaban Mylan
Agency product number
EMEA/H/C/005600
Active substance
rivaroxaban
International non-proprietary name (INN) or common name
rivaroxaban
Therapeutic area (MeSH)
  • Venous Thromboembolism
  • Pulmonary Embolism
  • Acute Coronary Syndrome
  • Stroke
  • Coronary Artery Disease
  • Peripheral Arterial Disease
  • Atrial Fibrillation
Anatomical therapeutic chemical (ATC) code
B01AF01
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
12/11/2021
Contact address

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Product information

12/11/2021 Rivaroxaban Mylan - EMEA/H/C/005600 -

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic 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. 

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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.

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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.
 

Assessment history

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