Basic Information
B01AF01
rivaroxaban
Antithrombotic agents
Therapeutic 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 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.
Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA) alone or with ASA plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).
Rivaroxaban Accord, 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.
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.
Overview Summary
Rivaroxaban Accord is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:
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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-occuring;
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to prevent venous thromboembolism (VTE, the formation of blood clots in the veins) in patients who are undergoing surgery to replace a hip or knee;
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to prevent stroke (caused by a blood clot in the brain) and systemic embolism (a blood clot in another organ) in patients with non‑valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart);
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to prevent atherothrombotic events (such as heart attack, stroke or death from heart disease) in patients:
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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;
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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 Accord contains the active substance rivaroxaban.
Rivaroxaban Accord is a ‘generic medicine’. This means that Rivaroxaban Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Xarelto.
Active Substances (1)
rivaroxaban
Documents (9)
Rivaroxaban Accord : EPAR - All authorised presentations
November 24, 2020
AUTHORISED_PRESENTATIONS
CHMP summary of positive opinion for Rivaroxaban Accord
September 18, 2020
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Rivaroxaban Accord : EPAR - Public assessment report
November 24, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Rivaroxaban Accord
September 18, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Rivaroxaban Accord : EPAR - Procedural steps taken and scientific information after authorisation
December 9, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Rivaroxaban Accord : EPAR - Medicine overview
November 24, 2020
OVERVIEW_DOCUMENT
Rivaroxaban Accord : EPAR - Public assessment report
November 24, 2020
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Rivaroxaban Accord : EPAR - Risk-management-plan summary
November 24, 2020
RISK_MANAGEMENT_PLAN_SUMMARY
Rivaroxaban Accord : EPAR - Product information
November 24, 2020
DRUG_PRODUCT_INFORMATION
Overview Q&A (7)
Question
How is Rivaroxaban Accord used?
Answer
Rivaroxaban Accord is available as tablets (2.5, 10, 15 and 20 mg). The dose and duration of treatment with Rivaroxaban Accord depend on what it is being used for and the patient's risk of bleeding. It is given at a lower dose (2.5 mg twice daily) when used in combination with an antiplatelet medicine such as acetylsalicylic acid (aspirin) or ticlopidine. The doctor will regularly evaluate the benefits of ongoing treatment against the risk of excessive or internal bleeding.
The medicine can only be obtained with a prescription. For more information about using Rivaroxaban Accord, see the package leaflet or contact your doctor or pharmacist.
Question
How does Rivaroxaban Accord work?
Answer
The active substance in Rivaroxaban Accord, 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.
Question
How has Rivaroxaban Accord been studied?
Answer
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 Rivaroxaban Accord.
As for every medicine, the company provided studies on the quality of Rivaroxaban Accord. 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.
Question
What are the benefits and risks of Rivaroxaban Accord?
Answer
Because Rivaroxaban Accord 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.
Question
Why is Rivaroxaban Accord authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Rivaroxaban Accord 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 Rivaroxaban Accord outweigh the identified risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Rivaroxaban Accord?
Answer
The company that markets Rivaroxaban Accord will provide an educational pack for doctors who prescribe Rivaroxaban Accord, containing important safety information including on the risk of bleeding during treatment with Rivaroxaban Accord and how to manage this risk. In addition, prescribers will receive a patient alert card to give to patients receiving Rivaroxaban Accord containing key safety reminders for patients.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rivaroxaban Accord have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Rivaroxaban Accord are continuously monitored. Side effects reported with Rivaroxaban Accord are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Rivaroxaban Accord
Answer
Rivaroxaban Accord received a marketing authorisation valid throughout the EU on 16 November 2020.