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

boehringer ingelheim pty ltd - dabigatran etexilate mesilate, quantity: 172.95 mg (equivalent: dabigatran etexilate, qty 150 mg) - capsule, hard - excipient ingredients: dimeticone 350; purified talc; hyprolose; purified water; indigo carmine; hypromellose; carrageenan; acacia; potassium chloride; titanium dioxide; tartaric acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see section 4.2 dose and method of administration for details of treatment duration). 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 in adults.

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

boehringer ingelheim pty ltd - dabigatran etexilate mesilate, quantity: 126.83 mg (equivalent: dabigatran etexilate, qty 110 mg) - capsule, hard - excipient ingredients: hyprolose; hypromellose; tartaric acid; dimeticone 350; potassium chloride; acacia; purified talc; titanium dioxide; carrageenan; indigo carmine; purified water; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see section 4.2 dose and method of administration for details of treatment duration). 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 in adults.

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

boehringer ingelheim pty ltd - dabigatran etexilate mesilate, quantity: 86.48 mg (equivalent: dabigatran etexilate, qty 75 mg) - capsule, hard - excipient ingredients: hypromellose; titanium dioxide; potassium chloride; purified talc; carrageenan; tartaric acid; hyprolose; purified water; acacia; dimeticone 350; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see section 4.2 dose and method of administration for details of treatment duration). 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 in adults.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - dabigatran etexilate mesilate - venous thromboembolism; arthroplasty, replacement - antithrombotic agents - prevention of venous thromboembolic events

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate