Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
Capecitabine Accord is a cancer medicine that is used to treat:
- colon (large bowel) cancer. Capecitabine Accord is used on its own or with other cancer medicines in patients who have had surgery for stage III or Dukes’ stage C colon cancer;
- metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body). Capecitabine Accord is used on its own or with other cancer medicines;
- advanced gastric (stomach) cancer. Capecitabine Accord is used with other cancer medicines, including a platinum-containing cancer medicine such as cisplatin;
- locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body). Capecitabine Accord is used with docetaxel (another cancer medicine) after treatment with anthracyclines (another type of cancer medicine) has failed. It can also be used on its own when treatment with both anthracyclines and taxanes (another type of cancer medicine) has failed or when further treatment with anthracyclines is not suitable for the patient.
Capecitabine Accord is a ‘generic’ and a ‘hybrid’ medicine. This means that it is similar to a ‘reference medicine’, but it contains capecitabine at a new strength in addition to existing strengths. While the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Capecitabine Accord is also available as 300 mg tablets.
Capecitabine Accord contains the active substance capecitabine.
Active Substances (1)
capecitabine
Documents (12)
Capecitabine Accord : EPAR - Public assessment report
May 6, 2012
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Capecitabine Accord : EPAR - Procedural steps taken and scientific information after authorisation
June 24, 2013
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Capecitabine Accord-H-C-2386-A31-1481-C-2386-32 : EPAR - Assessment report - Variation
August 3, 2020
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CHMP summary of positive opinion for Capecitabine Accord
February 16, 2012
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Capecitabine Accord : EPAR - Public assessment report
May 6, 2012
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of positive opinion for Capecitabine Accord
February 16, 2012
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Capecitabine Accord-H-C-PSUSA-00000531-202404 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
May 5, 2025
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Capecitabine Accord : EPAR - Scientific conclusions - Annex IV
August 3, 2020
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Capecitabine Accord-H-C-PSUSA-00000531-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
August 26, 2019
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Capecitabine Accord : EPAR - Medicine overview
May 6, 2012
OVERVIEW_DOCUMENT
Capecitabine Accord : EPAR - All Authorised presentations
May 6, 2012
AUTHORISED_PRESENTATIONS
Capecitabine Accord : EPAR - Product Information
May 7, 2012
DRUG_PRODUCT_INFORMATION
Overview Q&A (7)
Question
How is Capecitabine Accord used?
Answer
Capecitabine Accord should only be prescribed by a doctor who is qualified in the use of cancer medicines.
Before starting treatment, it is recommended that patients are tested to check that they have a working dihydropyrimidine dehydrogenase (DPD) enzyme.
Capecitabine Accord is available as tablets (150, 300 and 500 mg). The dose depends on the patient’s height and weight and the type of cancer being treated. Capecitabine Accord tablets should be taken within 30 minutes after a meal. The tablets are given twice daily for 14 days followed by a 7-day gap before the next course.
Treatment is continued for six months after colon surgery. For other types of cancer, treatment is stopped if the disease gets worse or the side effects are unacceptable. Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects. For patients with partial DPD deficiency, a lower starting dose may be considered. For patients with partial DPD deficiency, a lower starting dose may be considered.
For more information about using Capecitabine Accord, see the package leaflet or contact your doctor or pharmacist.
Question
How does Capecitabine Accord work?
Answer
The active substance in Capecitabine Accord, capecitabine, is a cytotoxic medicine (a medicine that kills rapidly dividing cells, such as cancer cells) that belongs to the group ‘anti-metabolites’. Capecitabine is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues.
Fluorouracil is very similar to pyrimidine. Pyrimidine is part of the genetic material of cells (DNA and RNA). In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it stops the growth of tumour cells and eventually kills them.
Question
Why is Capecitabine Accord authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Capecitabine Accord has been shown to have comparable quality and to be bioequivalent to Xeloda. Therefore, the Agency’s view was that, as for Xeloda, the benefits of Capecitabine Accord outweigh the identified risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Capecitabine Accord?
Answer
Capecitabine Accord received a marketing authorisation valid throughout the European Union on 19 November 2012.
Question
Other information about Capecitabine Accord
Answer
The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Accord on 20 April 2012.
For more information about treatment with Capecitabine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Question
What are the benefits and risks of Capecitabine Accord?
Answer
Because Capecitabine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
How has Capecitabine Accord been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Xeloda, and do not need to be repeated for Capecitabine Accord.
As for every medicine, the company provided studies on the quality of Capecitabine Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.