🇧🇷 Pradaxa in Brazil

Pradaxa (dabigatran-etexilate) regulatory status in Brazil.

Marketing authorisation

ANVISA

  • 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 Brazil

Frequently asked questions

Is Pradaxa approved in Brazil?

Yes. ANVISA has authorised it.

Who is the marketing authorisation holder for Pradaxa in Brazil?

Boehringer Ingelheim is the originator. The local marketing authorisation holder may differ — check the official source linked above.