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- Capecitabine Accord
Community Register of medicinal products
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: | L - Antineoplastic and immunomodulating agents L01 - Cytostatics L01B - Antimetabolites L01BC - Pyrimidine analogues 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
5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 | ||||
| 08/04/2013 | Centralised - Variation | EMEA/H/C/2386/N/1 | ||||
| 18/04/2013 | Centralised - Variation | EMEA/H/C/2386/IB/4 | ||||