Capecitabine Medac

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capecitabine

Authorised
This medicine is authorised for use in the European Union.

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. For more information on generic and hybrid medicines, see the question-and-answer document here.

Capecitabine medac contains the active substance capecitabine.

This EPAR was last updated on 05/08/2020

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
GenericGeneric

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
10
Date of issue of marketing authorisation valid throughout the European Union
19/11/2012
Contact address

Fehlandtstraße 3
D-20354 Hamburg
Germany

Product information

16/07/2020 Capecitabine Medac - EMEA/H/C/002568 - IB/0023

Contents

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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.

Assessment history

Changes since initial authorisation of medicine

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