Capecitabine SUN

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capecitabine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Capecitabine SUN has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 22/12/2016

Authorisation details

Product details
Name
Capecitabine SUN
Agency product number
EMEA/H/C/002050
Active substance
capecitabine
International non-proprietary name (INN) or common name
capecitabine
Therapeutic area (MeSH)
  • Stomach Neoplasms
  • Breast Neoplasms
  • Colonic Neoplasms
  • 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
Sun Pharmaceutical Industries Europe B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
21/06/2013
Contact address

Polarisavenue 87
NL-2132 JH Hoofddorp
The Netherlands

Product information

21/06/2016 Capecitabine SUN - EMEA/H/C/002050 - IB/0007

Contents

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Pharmacotherapeutic group

capecitabine

Therapeutic indication

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

Capecitabine is indicated for the treatment of metastatic colorectal cancer.

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

Capecitabine 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 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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