Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Erbitux   
Auth. number : EU/1/04/281
INN : cetuximab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC06 - Cetuximab
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Merck KGaA
64271 Darmstadt

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/07/2004 Centralised - Authorisation EMEA/H/C/558 (2004)2509 of 29/06/2004
06/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/2
03/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/1
14/09/2005 Centralised - Variation EMEA/H/C/558/II/4 (2005)3538 of 13/09/2005
21/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/7
21/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/6
07/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/8
31/03/2006 Centralised - Variation EMEA/H/C/558/II/5 (2006)1339 of 29/03/2006
22/02/2007 Centralised - Variation EMEA/H/C/558/X/9 (2007)610 of 20/02/2007
01/03/2007 Centralised - Variation EMEA/H/C/558/II/10 (2007)708 of 27/02/2007
16/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/IB/12
14/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/IA/14, 15, 17, 18
25/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/IA/16
03/08/2007 Centralised - Notification EMEA/H/C/558/N/13
Updated with Decision(2008)834 of 28/02/2008
23/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/19
15/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/IB/23
26/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/21
03/03/2008 Centralised - Variation EMEA/H/C/558/II/22 (2008)834 of 28/02/2008
03/06/2008 Centralised - Variation EMEA/H/C/558/IB/25
Updated with Decision(2008)3915 of 17/07/2008
23/07/2008 Centralised - Variation EMEA/H/C/558/II/20 (2008)3915 of 17/07/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/24
28/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/27
26/11/2008 Centralised - Variation EMEA/H/C/558/II/26, 28 (2008)7499 of 24/11/2008
19/06/2009 Centralised - Renewal EMEA/H/C/558/R/30 (2009)5021 of 17/06/2009
04/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/IA/31
07/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/IA/34
08/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/32
22/01/2010 Centralised - Variation (rejected) EMEA/H/C/558/II/29 (2010)375 of 20/01/2010
07/06/2010 Centralised - Variation EMEA/H/C/558/II/33 (2010)3636 of 02/06/2010
29/07/2010 Centralised - Variation EMEA/H/C/558/IB/38
Updated with Decision(2010)7827 of 05/11/2010
02/08/2010 Centralised - Variation EMEA/H/C/558/II/35 (2010)5385 of 28/07/2010
08/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/37
09/11/2010 Centralised - Variation EMEA/H/C/558/II/39 (2010)7827 of 05/11/2010
07/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/IB/40
10/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/558/II/36/G
21/04/2011 Centralised - Variation EMEA/H/C/558/II/41 (2011)2848 of 18/04/2011
27/06/2011 Centralised - Variation EMEA/H/C/558/II/42 (2011)4628 of 23/06/2011
26/10/2011 Centralised - Variation EMEA/H/C/558/II/44/G (2011)7795 of 24/10/2011
17/01/2012 Centralised - Variation EMEA/H/C/558/II/47 (2012)190 of 13/01/2012
08/02/2012 Centralised - Variation EMEA/H/C/558/II/48 (2012)768 of 06/02/2012
03/09/2012 Centralised - Variation EMEA/H/C/558/II/52/G (2012)6144 of 30/08/2012
13/12/2012 Centralised - Variation EMEA/H/C/558/II/57
Updated with Decision(2013)9739 of 18/12/2013
21/02/2013 Centralised - Variation EMEA/H/C/558/II/58
Updated with Decision(2013)9739 of 18/12/2013
18/12/2013 Centralised - Variation EMEA/H/C/558/II/59
23/12/2013 Centralised - 2-Monthly update EMEA/H/C/558/II/62 (2013)9739 of 18/12/2013
28/03/2014 Centralised - Variation EMEA/H/C/558/IB/65/G
26/06/2014 Centralised - Variation EMEA/H/C/558/II/66