Revised: 2 April 2013
Publications
Pradaxa (dabigatran)
Medsafe received a request for information about Pradaxa on 30 September 2011, under the Official Information Act 1982 (OIA).
The information released in response to this request can be viewed by clicking on the links below:
- Medsafe letter in response to the OIA request (PDF 432KB, 2 pages)
- Clinical assessment of Boehringer's initial application for Pradaxa, granted in 2008 (PDF 8.5MB, 20 pages)
- Clinical assessment of Boehringer's application for an additional indication, granted in 2011 (PDF 3.7MB, 78 pages)
- Reports of suspected adverse reactions associated with Pradaxa, received by CARM up to 30 September 2011 (PDF 1.4MB, 38 pages)
