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The marketing authorisation for Capecitabine SUN has been withdrawn at the request of the marketing-authorisation holder.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
Product information
Capecitabine SUN : EPAR - Product Information
Latest procedure affecting product information: IB/0007
21/06/2016
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
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
capecitabineTherapeutic 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
Capecitabine SUN : EPAR - Procedural steps taken and scientific information after authorisation