Zaltrap

RSS

aflibercept

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

For practical information about using Zaltrap, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 12/10/2017

Authorisation details

Product details
Name
Zaltrap
Agency product number
EMEA/H/C/002532
Active substance
aflibercept
International non-proprietary name (INN) or common name
aflibercept
Therapeutic area (MeSH)
Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XX44
Publication details
Marketing-authorisation holder
Sanofi-Aventis Groupe
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
01/02/2013
Contact address
54 rue La Boétie
F-75008 Paris
France

Product information

21/09/2017 Zaltrap - EMEA/H/C/002532 - R/0037

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of metastatic colorectal cancer (MCRC).

Assessment history

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