Ondexxya

AstraZeneca AB,SE-151 85 Sodertalje,Sweden🇪🇺 European Union

EMA Page

Authorised Date: Apr 26, 2019
Approval ID: 6dacef7fc272a68f
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

<p>Ondexxya is a medicine used for stopping life-threatening or uncontrolled bleeding in adults taking the anticoagulant medicines apixaban or rivaroxaban.</p><p>Ondexxya contains the active substance andexanet alfa.</p>

Therapeutic & Classification

Therapeutic Indication

<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>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.</p> </div>

Therapeutic Area (MeSH)

Drug-Related Side Effects and Adverse Reactions

ATC Code

V03AB

ATC Item

N/A

Pharmacotherapeutic Group

All other therapeutic products

Active Substances

Active Substance (Summary)

andexanet alfa

INN / Common Names

andexanet alfa

Active Substance Details

Substance	CAS	Monograph
andexanet alfa	N/A	andexanet alfa

Quick Info

Approval ID6dacef7fc272a68f

Product NumberN/A

StatusAuthorised

Authorised DateApr 26, 2019

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Ondexxya

Medicine Name

Ondexxya

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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