Capecitabine SUN

capecitabine

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The marketing authorisation for Capecitabine SUN has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Capecitabine SUN : EPAR - Summary for the public BG = bălgarski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public ES = español 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public CS = čeština 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public DA = dansk 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public DE = Deutsch 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public ET = eesti keel 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public EL = elliniká 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public EN = English 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public FR = français 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public IT = italiano 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public LV = latviešu valoda 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public LT = lietuvių kalba 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public HU = magyar 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public MT = Malti 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public NL = Nederlands 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public PL = polski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public PT = português 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public RO = română 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public SK = slovenčina 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public SL = slovenščina 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public FI = suomi 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public SV = svenska 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Summary for the public HR = Hrvatski 2013-07-05 2016-12-22

This EPAR was last updated on 22/12/2016 .

Authorisation details

Product details

Product details for Capecitabine SUN
NameCapecitabine SUN
Agency product numberEMEA/H/C/002050
Active substance

capecitabine

International non-proprietary name (INN) or common name

capecitabine

Therapeutic area Colorectal NeoplasmsColonic NeoplasmsStomach NeoplasmsBreast Neoplasms
Anatomical therapeutic chemical (ATC) code L01BC06
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Capecitabine SUN
Marketing-authorisation holder

Sun Pharmaceutical Industries Europe B.V.

Revision3
Date of issue of marketing authorisation valid throughout the European Union21/06/2013

Contact address:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
NL-2132 JH Hoofddorp
The Netherlands

Product information

Product information

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

Name Language First published Last updated
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - Product Information HR = Hrvatski 2013-07-05 2016-12-22

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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.


Name Language First published Last updated
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22
Capecitabine SUN : EPAR - All Authorised presentations HR = Hrvatski 2013-07-05 2016-12-22

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Capecitabine SUN : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-08-29 2016-12-22

Initial marketing-authorisation documents

Name Language First published Last updated
Capecitabine SUN : EPAR - Public assessment report HR = Hrvatski 2013-07-05 2016-12-22
CHMP summary of positive opinion for Capecitabine SUN HR = Hrvatski 2013-04-26 2016-12-22

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Capecitabine SUN