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PRADAXA

150 Milligram Capsules Hard

Boehringer Ingelheim International GmbHEU/1/08/442/009-013

Main Information

Trade NamePRADAXA
Active SubstancesDABIGATRAN ETEXILATE MESILATE
Strength150 Milligram
Dosage FormCapsules Hard
Licence HolderBoehringer Ingelheim International GmbH
Licence NumberEU/1/08/442/009-013

Group Information

ATC CodeB01AE07 Direct thrombin inhibitors

Status

Authorised/WithdrawnAuthorised
Licence Issued01/08/2011
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may be renewed (B)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of Licence

Documents

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

Educational Materials - HCP

Educational Pack
VTE Prescriber guide
DVT/PE Prescriber Guide

Educational Materials - Patient

Patient Alert Card
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