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.
Vectibix : EPAR - Summary for the public (PDF/90.81 KB)
First published: 18/06/2009
Last updated: 12/05/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Amgen Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
04/06/2018 Vectibix - EMEA/H/C/000741 - IG/0946
- 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.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 201527/02/2015