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ACTIVE SUBSTANCE / INN

DABIGATRAN ETEXILATE

Brand name(s): Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma), Pradaxa, Dabigatran Etexilate Accord, Dabigatran etexilate Teva
EMA LISTED
APPLICATION WITHDRAWN
AUTHORISED
Venous Thromboembolism;Arthroplasty, Replacement
Arthroplasty, Replacement;Venous Thromboembolism
ACTIVE SUBSTANCE
Dabigatran Etexilate
REGULATORS
EMA
SPONSORS / MAH
Teva GmbH, Boehringer Ingelheim International GmbH, Accord Healthcare S.L.U.
TOTAL APPLICATIONS
4
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
PradaxaBoehringer Ingelheim International GmbHAuthorised17/03/2008Arthroplasty, Replacement;Venous Thromboembolism
Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)Teva GmbHAuthorised19/02/2024Venous Thromboembolism;Arthroplasty, Replacement
Dabigatran Etexilate AccordAccord Healthcare S.L.U.Authorised26/05/2023Venous Thromboembolism;Arthroplasty, Replacement
Dabigatran etexilate TevaTeva GmbHApplication withdrawnVenous Thromboembolism

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