Canada - English - Health Canada

boehringer ingelheim (canada) ltd ltee - dabigatran etexilate (dabigatran etexilate mesilate) - capsule - 75mg - dabigatran etexilate (dabigatran etexilate mesilate) 75mg - direct thrombin inhibitors

Canada - English - Health Canada

boehringer ingelheim (canada) ltd ltee - dabigatran etexilate (dabigatran etexilate mesilate) - capsule - 110mg - dabigatran etexilate (dabigatran etexilate mesilate) 110mg - direct thrombin inhibitors

Canada - English - Health Canada

boehringer ingelheim (canada) ltd ltee - dabigatran etexilate (dabigatran etexilate mesilate) - capsule - 150mg - dabigatran etexilate (dabigatran etexilate mesilate) 150mg - direct thrombin inhibitors

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - dabigatran etexilate mesylate 126.83mg equivalent to dabigatran etexilate 110 mg;  ;   - capsule - 110 mg - active: dabigatran etexilate mesylate 126.83mg equivalent to dabigatran etexilate 110 mg     excipient: acacia dimeticone hyprolose hypromellose hpmc capsule size 1 - (tt70-14-2-2) purified talc tartaric acid tekprint black sw-9008 - prevention of venous thromboembolic events in patients who have undergone major orthopaedic surgery.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - dabigatran etexilate mesylate 172.95mg equivalent to dabigatran etexilate 150 mg;  ;   - capsule - 150 mg - active: dabigatran etexilate mesylate 172.95mg equivalent to dabigatran etexilate 150 mg     excipient: acacia dimeticone hyprolose hypromellose hpmc capsule size 0 (tt70-14-2-4) purified talc tartaric acid tekprint black sw-9008 - prevention of venous thromboembolic events in patients who have undergone major orthopaedic surgery.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - dabigatran etexilate mesylate 86.48mg equivalent to dabigatran etexilate 75 mg;  ;   - capsule - 75 mg - active: dabigatran etexilate mesylate 86.48mg equivalent to dabigatran etexilate 75 mg     excipient: acacia dimeticone hyprolose hypromellose hpmc capsule size 2 - (tt70-14-2-3) purified talc tartaric acid tekprint black sw-9008 - prevention of venous thromboembolic events in patients who have undergone major orthopaedic surgery.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - dabigatran etexilate mesilate - capsule - 110mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - dabigatran etexilate mesilate - capsule - 150mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - dabigatran etexilate mesilate - capsule - 75mg

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - dabigatran etexilate mesilate - arthroplasty, replacement; venous thromboembolism - antithrombotic agents - pradaxa 75 mgprimary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.pradaxa 110 mgprimary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischemic attack (tia); age ≥ 75 years; heart failure (nyha class ≥ ii); diabetes mellitus; hypertension.treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.pradaxa 150 mgprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischemic attack (tia); age ≥ 75 years; heart failure (nyha class ≥ ii); diabetes mellitus; hypertension.treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.