Erbitux
cetuximab
Table of contents
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.
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) |
|
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 |
Product information
25/05/2022 Erbitux - EMEA/H/C/000558 - IA/0093
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.