Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Capecitabine SUN   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Capecitabin SUN (DE)
   - Capecitabina SUN (PT)
Auth. number : EU/1/13/831
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 is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.
Capecitabine is indicated for the treatment of metastatic colorectal cancer.
Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen .
Capecitabine 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 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: Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, NL-2132 JH Hoofddorp, 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
25/06/2013 Centralised - Authorisation EMEA/H/C/2050 (2013)4014 of 21/06/2013
02/09/2013 Centralised - Variation EMEA/H/C/2050/IB/1
Updated with Decision(2014)6026 of 19/08/2014
02/05/2014 Centralised - Variation EMEA/H/C/2050/IB/3
Updated with Decision(2014)6026 of 19/08/2014
25/06/2014 Centralised - Variation EMEA/H/C/2050/IB/4
Updated with Decision(2014)6026 of 19/08/2014
21/08/2014 Centralised - Yearly update (2014)6026 of 19/08/2014