Erbitux

RSS

cetuximab

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

Overview

This is a summary of the European public assessment report (EPAR) for Erbitux. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Erbitux.

This EPAR was last updated on 19/07/2017

Authorisation details

Product details
Name
Erbitux
Agency product number
EMEA/H/C/000558
Active substance
cetuximab
International non-proprietary name (INN) or common name
cetuximab
Therapeutic area (MeSH)
  • Head and Neck Neoplasms
  • Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC06
Publication details
Marketing-authorisation holder
Merck KGaA
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
28/06/2004
Contact address
64271 Darmstadt
Germany

Product information

01/06/2017 Erbitux - EMEA/H/C/000558 - N/0077

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

Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer:

  • in combination with irinotecan-based chemotherapy;
  • in first-line in combination with FOLFOX;
  • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck:

  • in combination with radiation therapy for locally advanced disease;
  • in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

Assessment history

Changes since initial authorisation of medicine

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