Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ecansya   
Auth. number : EU/1/12/763
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: Ecansya is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.
Capecitabine Krka is indicated for the treatment of metastatic colorectal cancer.
Capecitabine Krka is indicated for first-line treatment of advanced gastric cancer in combination with a platinum based regimen.
Capecitabine Krka 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 Krka 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: Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija

  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/2605 (2012)2846 of 20/04/2012
09/08/2012 Centralised - Variation EMEA/H/C/2605/IAin/1
Updated with Decision(2012)7785 of 25/10/2012
12/11/2012 Centralised - Variation (2012)7785 of 25/10/2012
16/11/2012 Centralised - Variation EMEA/H/C/2605/IAin/2
Updated with Decision(2013)8157 of 15/11/2013
02/04/2013 Centralised - Variation EMEA/H/C/2605/IB/3
Updated with Decision(2013)8157 of 15/11/2013
08/04/2013 Centralised - Variation EMEA/H/C/2605/IB/4
Updated with Decision(2013)8157 of 15/11/2013
24/09/2013 Centralised - Variation EMEA/H/C/2605/IB/7
Updated with Decision(2013)8157 of 15/11/2013
19/11/2013 Centralised - Variation (2013)8157 of 15/11/2013
03/04/2014 Centralised - Variation EMEA/H/C/2605/IB/10/G