Capecitabine SUN
capecitabine
Table of contents
Overview
The marketing authorisation for Capecitabine SUN has been withdrawn at the request of the marketing-authorisation holder.
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) |
|
| 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 |
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 |
Product information
21/06/2016 Capecitabine SUN - EMEA/H/C/002050 - IB/0007
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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.