PRAXBIND (idarucizumab), antidote for dabigatran
ANTIDOTE - New medicinal product
Opinions on drugs -
Posted on
Oct 12 2016
Reason for request
Inclusion
No clinical benefit demonstrated when compared with current treatment
- PRAXBIND is a neutralising agent specific to the anticoagulant effect of dabigatran (PRADAXA).
- It is a humanized monoclonal antibody fragment that has Marketing Authorisation in adults treated with dabigatran etexilate when a rapid neutralisation of its anticoagulant effects is required due to a surgical emergency or urgent procedures, or in case of uncontrolled or life-threatening bleedings.
- From the available clinical data it is not possible to estimate the impact of PRAXBIND in terms of morbidity and mortality compared to current symptomatic treatments.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
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