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 25/05/2022

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
L01FE01
Publication details
Marketing-authorisation holder
Merck Europe B.V. 
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
29/06/2004
Contact address

Gustav Mahlerplein 102
Ito Toren
1082 MA Amsterdam
The Netherlands

Product information

25/05/2022 Erbitux - EMEA/H/C/000558 - IA/0093

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

For details, see section 5.1.

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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