Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Capecitabine Accord   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Capecitabin Accord (DE)
   - Capecitabina Accord (PT)
   - Kapecitabin Accord (SL)
Auth. number : EU/1/12/762
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: Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer
Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer
Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum based regimen
Capecitabine Accord in combination with docetaxel (see section 5.1) 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. Capecitabine Accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Marketing Authorisation Holder: Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, 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
25/04/2012 Centralised - Authorisation EMEA/H/C/2386 (2012)2845 of 20/04/2012
11/03/2013 Corrigendum (2012)2845 of 20/04/2012
26/03/2013 Centralised - Variation EMEA/H/C/2386/IAin/3/G
Updated with Decision(2014)1260 of 20/02/2014
08/04/2013 Centralised - Variation EMEA/H/C/2386/N/1
Updated with Decision(2014)1260 of 20/02/2014
18/04/2013 Centralised - Variation EMEA/H/C/2386/IB/4
Updated with Decision(2014)1260 of 20/02/2014
26/09/2013 Centralised - Variation EMEA/H/C/2386/IB/6
Updated with Decision(2014)1260 of 20/02/2014
22/02/2014 Centralised - Variation (2014)1260 of 20/02/2014
04/04/2014 Centralised - Variation EMEA/H/C/2386/IB/11/G