due to other medicines), or liver problems that could be life-threatening. Pradaxa should also not be used in patients taking quinidine (another medicine used to regulate the heart rhythm).
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Pradaxa’s benefits are greater than its risks for primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. The Committee recommended that Pradaxa be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Pradaxa to Boehringer Ingelheim International GmbH on 18 March 2008.
↑ back to table of contents ↑
Name
Pradaxa 110 mg hard capsules
Composition
Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate)
Excipients: Each hard capsule contains 3 micrograms sunset yellow (E110)
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Hard capsule
Imprinted capsules with light blue, opaque cap and cream-coloured, opaque body of size 1 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R110”.
Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!
