Ecansya (previously Capecitabine Krka)

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capecitabine

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

Overview

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

This EPAR was last updated on 31/10/2018

Authorisation details

Product details
Name
Ecansya (previously Capecitabine Krka)
Agency product number
EMEA/H/C/002605
Active substance
capecitabine
International non-proprietary name (INN) or common name
capecitabine
Therapeutic area (MeSH)
  • Colonic Neoplasms
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Stomach 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
Krka, d.d., Novo mesto
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
19/04/2012
Contact address
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

01/10/2018 Ecansya (previously Capecitabine Krka) - EMEA/H/C/002605 - IB/0021

Contents

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

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.

Ecansya is indicated for the treatment of metastatic colorectal cancer.

Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.

Ecansya 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. Ecansya 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

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