Capecitabine SUN

Withdrawn

This medicine's authorisation has been withdrawn

capecitabine

Overview

On 21 June 2016, the European Commission withdrew the marketing authorisation for Capecitabine SUN (capecitabine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sun Pharmaceutical Industries Europe, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Capecitabine SUN was granted marketing authorisation in the EU on 21 June 2013 for the following indications:

• adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer. Capecitabine is indicated for the treatment of metastatic colorectal cancer.
• first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.
• in combination with docetaxel 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. The marketing authorisation was initially valid for a 5-year period. 

Capecitabine SUN is a generic medicine of Xeloda. There are other generic medicinal products of Xeloda authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Capecitabine SUN is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Capecitabine SUN : EPAR - Summary for the public

Reference Number: EMA/411926/2013

Product information

Capecitabine SUN : EPAR - Product Information

Capecitabine SUN : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Capecitabine SUN
• Active substance:
  capecitabine
• International non-proprietary name (INN) or common name:
  capecitabine
• Therapeutic area (MeSH):
  • Stomach Neoplasms
  • Breast Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01BC06

Pharmacotherapeutic group

capecitabine

Therapeutic 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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/002050
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Sun Pharmaceutical Industries Europe B.V.

  Polarisavenue 87; 2132 JH Hoofddorp; The Netherlands

• Marketing authorisation issued:
  21/06/2013
• Withdrawal of marketing authorisation:
  21/06/2021
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Capecitabine SUN : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Capecitabine SUN : EPAR - Public assessment report

Reference Number: EMA/370014/2013

CHMP summary of positive opinion for Capecitabine SUN

Adopted Reference Number: EMA/CHMP/138360/2013