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.
Erbitux : EPAR - Summary for the public (PDF/87.78 KB)
First published: 14/07/2009
Last updated: 27/01/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
12/07/2019 Erbitux - EMEA/H/C/000558 - IAIN/0085/G
- 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.
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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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 201322/11/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 November 201118/11/2011
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 16-19 November 200920/11/2009