The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Pradaxa



Boehringer Ingelheim International GmbHEU/1/08/442/025

Main Information

Trade NamePradaxa
Active SubstancesDabigatran etexilate mesilate
Dosage FormCoated granules
Licence HolderBoehringer Ingelheim International GmbH
Licence NumberEU/1/08/442/025

Group Information

ATC CodeB01AE07 dabigatran etexilate

Status

License statusAuthorised
Licence Issued11/01/2021
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

Educational Materials - Patient

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