Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - rivaroxaban - film-coated tablet - rivaroxaban 2.5 mg - antithrombotic agents

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - rivaroxaban - film-coated tablet - rivaroxaban 10 mg - antithrombotic agents

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - rivaroxaban - film-coated tablet - rivaroxaban 15 mg - antithrombotic agents

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - rivaroxaban - film-coated tablet - rivaroxaban 20 mg - antithrombotic agents

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antithrombotic agents - 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. 

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antithrombotic agents - 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).adultsprevention 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 populationtreatment 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.adultsprevention 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 populationtreatment 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.

Israel - English - Ministry of Health

taro pharmaceutical industries ltd - rivaroxaban - film coated tablets - rivaroxaban 2.5 mg - rivaroxaban - rivaroxaban taro, co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel , is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers. rivaroxaban taro, 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.

Israel - English - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - rivaroxaban - film coated tablets - rivaroxaban 2.5 mg - rivaroxaban - rivaroxaban s.k, co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel , is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.rivaroxaban s.k,, 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

teva gmbh - rivaroxaban - film-coated tablet - rivaroxaban