Overview

The marketing authorisation for Capecitabine SUN has been withdrawn at the request of the marketing-authorisation holder.

Capecitabine SUN : EPAR - Summary for the public

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Product information

Capecitabine SUN : EPAR - Product Information

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español (ES) (1.51 MB - PDF)
čeština (CS) (1.87 MB - PDF)
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slovenščina (SL) (1.8 MB - PDF)
Suomi (FI) (1.53 MB - PDF)
svenska (SV) (1.48 MB - PDF)

Latest procedure affecting product information: IB/0007

21/06/2016

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This medicine’s product information is available in all official EU languages.
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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Capecitabine SUN : EPAR - All Authorised presentations

български (BG) (34.63 KB - PDF)
español (ES) (143.72 KB - PDF)
čeština (CS) (156.36 KB - PDF)
dansk (DA) (143.41 KB - PDF)
Deutsch (DE) (143.45 KB - PDF)
eesti keel (ET) (143.55 KB - PDF)
ελληνικά (EL) (171.62 KB - PDF)
français (FR) (143.56 KB - PDF)
hrvatski (HR) (291.72 KB - PDF)
íslenska (IS) (143.48 KB - PDF)
italiano (IT) (143.45 KB - PDF)
latviešu valoda (LV) (175.98 KB - PDF)
lietuvių kalba (LT) (159.9 KB - PDF)
magyar (HU) (161.07 KB - PDF)
Malti (MT) (157.72 KB - PDF)
Nederlands (NL) (143.46 KB - PDF)
norsk (NO) (143.3 KB - PDF)
polski (PL) (157 KB - PDF)
português (PT) (143.43 KB - PDF)
română (RO) (484.53 KB - PDF)
slovenčina (SK) (156.52 KB - PDF)
slovenščina (SL) (154.49 KB - PDF)
Suomi (FI) (144.55 KB - PDF)
svenska (SV) (143.55 KB - PDF)

Product details

Name of medicine
Capecitabine SUN
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

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.

Authorisation details

EMA product number
EMEA/H/C/002050

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.

Marketing authorisation holder
Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Marketing authorisation issued
21/06/2013
Revision
3

Assessment history

Capecitabine SUN : EPAR - Procedural steps taken and scientific information after authorisation

Capecitabine SUN : EPAR - Public assessment report

CHMP summary of positive opinion for Capecitabine SUN

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