Capecitabine SUN



This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Capecitabine SUN has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 22/12/2016

Authorisation details

Product details
Capecitabine SUN
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Stomach Neoplasms
  • Breast Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code

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.

Publication details
Marketing-authorisation holder
Sun Pharmaceutical Industries Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Product information

21/06/2016 Capecitabine SUN - EMEA/H/C/002050 - IB/0007

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


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.

Assessment history

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