Capecitabine SUN : EPAR - Summary for the public (PDF/222.38 KB)
First published: 05/07/2013
Last updated: 22/12/2016
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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.
Sun Pharmaceutical Industries Europe B.V.
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21/06/2016 Capecitabine SUN - EMEA/H/C/002050 - IB/0007
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.