Vectibix

RSS

panitumumab

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

Overview

This is a summary of the European Public Assessment Report (EPAR) for Vectibix. 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 Vectibix.

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

This EPAR was last updated on 11/09/2018

Authorisation details

Product details
Name
Vectibix
Agency product number
EMEA/H/C/000741
Active substance
panitumumab
International non-proprietary name (INN) or common name
panitumumab
Therapeutic area (MeSH)
Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC08
Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
03/12/2007
Contact address
Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

04/06/2018 Vectibix - EMEA/H/C/000741 - IG/0946

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

Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):

  • in first-line in combination with Folfox or Folfiri.
  • in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
  • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Assessment history

Changes since initial authorisation of medicine

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