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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Capecitabine Teva This product is authorized under a different brandname in the EU in the folowing languages: - Capecitabin Teva (DA) - Capecitabin Teva (DE) - Capecitabina Teva (ES) - Capecitabina Teva (PT) - Capecitabină Teva (RO) - Kapecitabin Teva (SL)|
|Auth. number :||EU/1/12/761|
|ATC:||Anatomical main group: L - Antineoplastic and immunomodulating agents|
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BC - Pyrimidine analogues
Chemical substance: L01BC06 - Capecitabine
(See WHO ATC Index)
|Indication:||Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer|
Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer.
Capecitabine Teva is indicated for first line treatment of advanced gastric cancer in combination with a platinum based regimen.
Capecitabine Teva 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 Teva 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.
|Marketing Authorisation Holder:||Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|25/04/2012||Centralised - Authorisation||EMEA/H/C/2362||(2012)2850 of 20/04/2012|
|11/03/2013||Centralised - Variation||EMEA/H/C/2362/IB/1|
|05/08/2013||Centralised - Variation||EMEA/H/C/2362/IB/6/G|
|11/09/2013||Centralised - Variation||EMEA/H/C/2362/IB/10|
|14/10/2013||Centralised - Variation||EMEA/H/C/2362/IAin/11|