Zaltrap

Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,FRANCE🇪🇺 European Union

EMA Page

Authorised Date: Feb 1, 2013
Approval ID: 0ff4cf12fcc33a4f
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

<p>This is a summary of the European public assessment report (EPAR) for Zaltrap. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zaltrap.</p><p>For practical information about using Zaltrap, patients should read the package leaflet or contact their doctor or pharmacist.</p>

Therapeutic & Classification

Therapeutic Indication

<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Treatment of metastatic colorectal cancer (MCRC).</p></div>

Therapeutic Area (MeSH)

Colorectal Neoplasms

ATC Code

L01XX44

ATC Item

N/A

Pharmacotherapeutic Group

Antineoplastic agents

Active Substances

Active Substance (Summary)

aflibercept

INN / Common Names

aflibercept

Active Substance Details

Substance	CAS	Monograph
aflibercept	N/A	aflibercept

Quick Info

Approval ID0ff4cf12fcc33a4f

Product NumberN/A

StatusAuthorised

Authorised DateFeb 1, 2013

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Zaltrap

Medicine Name

Zaltrap

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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