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dabigatran etexilate (Pradaxa)

Advice

following a full submission:

dabigatran etexilate (Pradaxa®) is accepted for use within NHS Scotland.

Indication under review: treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Dabigatran etexilate was non-inferior to a vitamin K antagonist for recurrent symptomatic venous thromboembolism events (VTE) and death related to VTE in three phase III studies (two in the treatment of DVT/PE and one in the prevention of recurrent DVT/PE).

The economic case was based on evidence relating to a maximum of 18 months treatment so the cost-effectiveness of longer term use is uncertain.
 

Drug Details

Drug Name: dabigatran etexilate (Pradaxa)
SMC Drug ID: 995/14
Manufacturer: Boehringer Ingelheim Ltd
Indication: For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
BNF Category:
Sub Category: 2.8 Anticoagulants and protamine
Submission Type: Full submission
Status: Accepted
Date Advice Published: 13 October 2014

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