We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
ANDEXXA (AstraZeneca Pty Ltd)
Product name
ANDEXXA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
206 (255 working days)
Active ingredients
andexanet alfa
Registration type
NCE/NBE
Indication
ANDEXXA (andexanet alfa) has provisional approval in Australia for adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
The decision to approve this indication has been made on the basis of haemostatic efficacy and reduction in anti-FXa activity. Continued approval of this indication depends on verification and description of benefit in a confirmatory trial.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration