Active-ingredient Dossier
Dabigatran Etexilate Mesilate
Active-ingredient Dossier for Dabigatran Etexilate Mesilate (direct thrombin inhibitor). Australian brands, products, PBS listings, PBAC outcomes —…
- Brand: PRADAXA
- Brand: DABIGATRAN SANDOZ
- Brand: DABIGATRAN VIATRIS
- Therapeutic area: Cardiology
What is
Dabigatran Etexilate Mesilate Dabigatran Etexilate Mesilate is a direct thrombin inhibitor.
Australian brands containing
Dabigatran Etexilate Mesilate — PRADAXA — ARX-DABIGATRAN — DABIGATRAN SANDOZ — DABIGATRAN VIATRIS
Therapeutic areas
Dabigatran Etexilate Mesilate is registered in Neurology (2 brands) and Haematology (2 brands).
Sponsor landscape
The ingredient is marketed by Arrotex Pharmaceuticals, Sandoz, Alphapharm and Boehringer Ingelheim.
PBS and regulatory activity
One brand with this ingredient is listed on the PBS, with the latest schedule date of 1 May 2026. The latest PBAC outcome was recorded on 1 November 2017, and the latest AusPAR was issued on 24 August 2015.