Capecitabine Medac
capecitabine
Table of contents
Overview
Capecitabine medac is a cancer medicine that is used to treat:
- colon (large bowel) cancer. Capecitabine medac 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 medac is used on its own or with other cancer medicines;
- advanced gastric (stomach) cancer. Capecitabine medac 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 medac 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 medac 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 medac is also available as 300 mg tablets.
Capecitabine medac contains the active substance capecitabine.
Authorisation details
| Product details | |
|---|---|
| Name |
Capecitabine Medac
|
| Agency product number |
EMEA/H/C/002568
|
| Active substance |
capecitabine
|
| International non-proprietary name (INN) or common name |
capecitabine
|
| Therapeutic area (MeSH) |
Colorectal Neoplasms
|
| Anatomical therapeutic chemical (ATC) code |
L01BC06
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
medac Gesellschaft für klinische Spezialpräparate mbH
|
| Revision |
13
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/11/2012
|
| Contact address |
Theaterstrasse 6 |
Product information
30/03/2023 Capecitabine Medac - EMEA/H/C/002568 - IB/0031/G
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Antineoplastic agents
Therapeutic indication
Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.
Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer.
Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.
Capecitabine Medac 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 Medac 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.