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Pradaxa



Boehringer Ingelheim International GmbHEU/1/08/442/031

Main Information

Trade NamePradaxa
Active SubstancesDabigatran etexilate mesilate
Dosage FormPowder and solvent for oral solution
Licence HolderBoehringer Ingelheim International GmbH
Licence NumberEU/1/08/442/031

Group Information

ATC CodeB01AE07 dabigatran etexilate

Status

License statusWithdrawn
Withdrawn Date09/11/2023
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
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