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PHARMACOR DABIGATRAN (Pharmacor Pty Ltd)
Product name
PHARMACOR DABIGATRAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
206 (255 working days)
Active ingredients
Dabigatran etexilate mesilate
Registration type
New generic medicine
Indication
DABIGATRAN is indicated for Prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). 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.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine