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Dabigatran (Pradaxa°) for venous thrombosis in children and adolescents

 Marketing Authorisations  Dabigatran, an anticoagulant of the thrombin inhibitor class authorised for use in adults after venous thrombosis, a situation in which it does not represent a therapeutic advance, has now also been authorised for patients less than 18 years of age.
Full article (2 pages) available for download by subscribers

The clinical evaluation of dabigatran in children mainly consists of one randomised non-blinded trial versus an anticoagulant chosen by the investigator (a vitamin K antagonist or heparin). 267 children and adolescents were included, 35 of whom were less than 2 years of age.

©Prescrire 1 May 2023

Source: "Dabigatran (Pradaxa°) for venous thrombosis in children and adolescents" Prescrire International 2023; 32 (248): 124-125. Subscribers only.

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