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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.