Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Capecitabine Teva   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Capecitabin Teva (DA)
   - Capecitabin Teva (DE)
   - Capecitabina Teva (ES)
   - Capecitabina Teva (PT)
   - Capecitabină Teva (RO)
   - Kapecitabin Teva (SL)
Auth. number : EU/1/12/761
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 Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer
Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer.
Capecitabine Teva is indicated for first line treatment of advanced gastric cancer in combination with a platinum based regimen.
Capecitabine Teva 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. Capecitabine Teva 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: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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/2362 (2012)2850 of 20/04/2012
06/03/2013 Centralised - Variation EMEA/H/C/2362/IB/1
Updated with Decision(2014)1261 of 20/02/2014
05/08/2013 Centralised - Variation EMEA/H/C/2362/IB/6/G
Updated with Decision(2014)1261 of 20/02/2014
11/09/2013 Centralised - Variation EMEA/H/C/2362/IB/10
Updated with Decision(2014)1261 of 20/02/2014
14/10/2013 Centralised - Variation EMEA/H/C/2362/IAin/11
Updated with Decision(2014)1261 of 20/02/2014
25/02/2014 Centralised - Yearly update (2014)1261 of 20/02/2014
03/04/2014 Centralised - Variation EMEA/H/C/2362/IB/13/G