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EMA approval · 2026-03-13

EMA Authorised: Pradaxa (dabigatran etexilate mesilate) — Boehringer Ingelheim International GmbH

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Summary

EMA has authorised Pradaxa (dabigatran etexilate mesilate) for use in patients undergoing arthroplasty replacement and for prevention of venous thromboembolism.

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Diseases / indications

Drugs mentioned

  • Pradaxa (dabigatran etexilate)

Snippet

Status: Authorised. Therapeutic area: Arthroplasty, Replacement;Venous Thromboembolism. MAH: Boehringer Ingelheim International GmbH. Decision date: 24/11/2025