Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Capecitabine medac   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Капецитабин medac (BG)
   - Capecitabin medac (DE)
   - Capecitabina medac (IT)
   - Capecitabina medac (PT)
   - Kapecitabin medac (SL)
Auth. number : EU/1/12/802
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 medac is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1).
  • Capecitabine medac is indicated for the treatment of metastatic colorectal cancer (see section 5.1).
  • Capecitabine medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1).
  • Capecitabine medac 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 medac 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: medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland

  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
23/11/2012 Centralised - Authorisation EMEA/H/C/2568 (2012)8599 of 19/11/2012
22/02/2013 Corrigendum (2013)8599 Cor of 20/02/2013
06/03/2013 Centralised - Variation EMEA/H/C/2568/IB/1
Updated with Decision(2014)1469 of 28/02/2014
06/09/2013 Centralised - Variation EMEA/H/C/2568/IB/4
Updated with Decision(2014)1469 of 28/02/2014
26/09/2013 Centralised - Variation EMEA/H/C/2568/IB/3
Updated with Decision(2014)1469 of 28/02/2014
20/11/2013 Centralised - Variation EMEA/H/C/2568/IA/6
Updated with Decision(2014)1469 of 28/02/2014
04/03/2014 Centralised - Yearly update (2014)1469 of 28/02/2014
03/04/2014 Centralised - Variation EMEA/H/C/2568/IB/7/G
24/06/2014 Centralised - Variation EMEA/H/C/2568/IA/8/G