Capecitabine Medac



This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Capecitabine Medac. 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 Medac.

This EPAR was last updated on 26/11/2019

Authorisation details

Product details
Capecitabine Medac
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code

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
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Fehlandtstraße 3
D-20354 Hamburg

Product information

10/10/2019 Capecitabine Medac - EMEA/H/C/002568 - IB/0022


Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating
1 rating