Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xeloda   
Auth. number : EU/1/00/163
INN : capecitabine
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BC - Pyrimidine analogues
Chemical substance: L01BC06 - Capecitabine
(See WHO ATC Index)
Indication: Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.
Xeloda is indicated for the treatment of metastatic colorectal cancer.
Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinumbased regimen. Xeloda in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Xeloda is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracyclinecontaining chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

  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
03/02/2001 Centralised - Authorisation EMEA/H/C/316 (2001)209 of 02/02/2001
25/03/2002 Centralised - Variation EMEA/H/C/316/II/1 (2002)1270 of 21/03/2002
11/03/2003 Centralised - Variation EMEA/H/C/316/I/3
11/03/2003 Centralised - Variation EMEA/H/C/316/I/6
11/03/2003 Centralised - Variation EMEA/H/C/316/I/7
11/03/2003 Centralised - Variation EMEA/H/C/316/I/5
11/03/2003 Centralised - Variation EMEA/H/C/316/I/4
26/03/2004 Centralised - Variation EMEA/H/C/316/II/8 (2004)1204 of 25/03/2004
07/03/2005 Centralised - Variation EMEA/H/C/316/IA/10
07/03/2005 Centralised - Variation EMEA/H/C/316/IA/11
01/04/2005 Centralised - Variation EMEA/H/C/316/II/9 (2005)1082 of 30/03/2005
17/08/2005 Centralised - Variation EMEA/H/C/316/IA/13
04/10/2005 Centralised - Variation EMEA/H/C/316/IA/14
Updated with Decision(2006)450 of 09/02/2006
20/10/2005 Centralised - Variation EMEA/H/C/316/II/12
18/01/2006 Centralised - Variation EMEA/H/C/316/IA/16
13/02/2006 Centralised - Renewal EMEA/H/C/316/R/25 (2006)450 of 09/02/2006
02/06/2006 Centralised - Variation EMEA/H/C/316/II/17 (2006)2234 of 31/05/2006
13/10/2006 Centralised - Variation EMEA/H/C/316/IA/20
Updated with Decision(2007)1511 of 28/03/2007
20/10/2006 Centralised - Variation EMEA/H/C/316/IA/22
20/10/2006 Centralised - Variation EMEA/H/C/316/IA/23
15/11/2006 Centralised - Variation EMEA/H/C/316/IB/21
18/12/2006 Centralised - Variation EMEA/H/C/316/IB/19
19/12/2006 Centralised - Variation EMEA/H/C/316/IA/24
16/02/2007 Centralised - Variation EMEA/H/C/316/IA/27
30/03/2007 Centralised - Variation EMEA/H/C/316/II/18 (2007)1511 of 28/03/2007
03/04/2007 Centralised - Variation EMEA/H/C/316/IB/25
03/04/2007 Centralised - Variation EMEA/H/C/316/IB/26
25/07/2007 Centralised - Variation EMEA/H/C/316/IA/30
21/09/2007 Centralised - Variation EMEA/H/C/316/IB/29
13/12/2007 Centralised - Variation EMEA/H/C/316/IA/32
Updated with Decision(2008)443 of 31/01/2008
04/02/2008 Centralised - Variation EMEA/H/C/316/II/28 (2008)443 of 31/01/2008
31/03/2008 Centralised - Variation EMEA/H/C/316/II/33 (2008)1253 of 27/03/2008
04/11/2008 Centralised - Variation EMEA/H/C/316/II/34 (2008)6658 of 31/10/2008
03/04/2009 Centralised - Variation EMEA/H/C/316/II/35
14/04/2009 Centralised - Variation EMEA/H/C/316/IB/36
15/04/2009 Centralised - Variation EMEA/H/C/316/IA/37
15/04/2009 Centralised - Variation EMEA/H/C/316/IA/38
02/06/2009 Centralised - Variation EMEA/H/C/316/IA/39
17/06/2009 Centralised - Variation EMEA/H/C/316/IB/40
30/07/2009 Centralised - Variation EMEA/H/C/316/IB/41
25/03/2010 Centralised - Variation EMEA/H/C/316/II/44 (2010)2001 of 23/03/2010
15/06/2010 Centralised - Variation EMEA/H/C/316/IB/45/G
22/06/2010 Centralised - Variation EMEA/H/C/316/IB/45/G
06/08/2010 Centralised - Variation EMEA/H/C/316/IA/46
06/08/2010 Centralised - Variation EMEA/H/C/316/II/43
21/06/2011 Centralised - Variation EMEA/H/C/316/II/47 (2011)4459 of 17/06/2011
11/09/2012 Centralised - Variation EMEA/H/C/316/N/50
Updated with Decision(2013)8701 of 29/11/2013
24/09/2012 Referral EMEA/H/C/316/A-20/48 (2012)6699 of 20/09/2012
15/11/2012 Centralised - Variation EMEA/H/C/316/II/49
Updated with Decision(2013)8701 of 29/11/2013
30/05/2013 Centralised - Variation EMEA/H/C/316/II/53
Updated with Decision(2013)8701 of 29/11/2013
03/12/2013 Centralised - Variation (2013)8701 of 29/11/2013
18/12/2013 Centralised - Variation EMEA/H/C/316/II/55
23/12/2013 Centralised - Variation EMEA/H/C/316/II/54 (2013)9748 of 18/12/2013
23/01/2014 Centralised - Variation EMEA/H/C/316/II/57/G
04/03/2014 Centralised - Variation EMEA/H/C/316/N/59