This is a summary of the European public assessment report (EPAR) for Capecitabine Accord. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Capecitabine Accord.
Capecitabine Accord : EPAR - Summary for the public (PDF/60.39 KB)
First published: 07/05/2012
Last updated: 07/05/2012
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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.
Accord Healthcare S.L.U.
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02/04/2019 Capecitabine Accord - EMEA/H/C/002386 - PSUSA/00000531/201804
- 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
Please note that the size of the above document can exceed 50 pages.
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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 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.