TGA
- Status: likely_approved
🇦🇺 Pradaxa in Australia
Pradaxa (dabigatran etexilate) regulatory status in Australia.
Marketing authorisations
TGA
- Status: likely_approved
TGA
- Status: likely_approved
TGA
- Status: likely_approved
TGA
- Status: likely_approved
Pradaxa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in Australia
Frequently asked questions
Is Pradaxa approved in Australia?
Yes. TGA has authorised it; TGA has authorised it; TGA has authorised it.
Who is the marketing authorisation holder for Pradaxa in Australia?
Generic (originally Boehringer Ingelheim) is the originator. The local marketing authorisation holder may differ — check the official source linked above.