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

denk pharma gmbh & co. kg prinzregentenstrasse 79 81675 münchen , germany - apixaban - film-coated tablet - apixaban 2.5 mg - antithrombotic agents

Malta - English - Medicines Authority

denk pharma gmbh & co. kg prinzregentenstrasse 79 81675 münchen , germany - apixaban - film-coated tablet - apixaban 5 mg - antithrombotic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - apixaban - film-coated tablet - 2.5 milligram(s) - apixaban

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - apixaban - film-coated tablet - 5 milligram(s) - apixaban

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. 

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd - apixaban - film-coated tablet - apixaban

United States - English - NLM (National Library of Medicine)

indoco remedies limited - apixaban (unii: 3z9y7uwc1j) (apixaban - unii:3z9y7uwc1j) - apixaban tablets are indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. apixaban tablets are indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe), in patients who have undergone hip or knee replacement surgery. apixaban tablets are indicated for the treatment of dvt. apixaban tablets are indicated for the treatment of pe. apixaban tablets are indicated to reduce the risk of recurrent dvt and pe following initial therapy. apixaban tablets are contraindicated in patients with the following conditions: • active pathological bleeding [see warnings and precautions (5.2) and adverse  reactions(6.1)] • severe  hypersensitivity  reaction  to  apixaban (e.g.,  anaphylactic  reactions)  [see  adverse reactions (6.1)] risk summary the limited available data on apixaban tablets  use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental

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.

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - rivaroxaban, quantity: 20 mg - tablet, film coated - excipient ingredients: hypromellose; iron oxide red; titanium dioxide; croscarmellose sodium; sodium lauryl sulfate; microcrystalline cellulose; lactose monohydrate; purified talc; macrogol 4000 - rivaroxaban is indicated for:,? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe.