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Community Register of medicinal products

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Docetaxel Teva Pharma   
Auth. number : EU/1/10/662
INN : Docetaxel
ATC: L - Antineoplastic and immunomodulating agents
L01 - Cytostatics
L01C - Plant alkaloids and other natural products
L01CD - Taxanes
L01CD02 - Docetaxel
(See WHO ATC Index)
Indication: Breast cancer
  • Docetaxel Teva Pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

    • Non-small cell lung cancer
  • Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

  • Docetaxel Teva Pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.

    • Prostate cancer
  • Docetaxel Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

    • Marketing Authorisation Holder: Teva Pharma B.V.
    Computerweg 10, NL-3542 DR Utrecht, Nederland

      EPAR and active package presentations

    Package presentations

    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.

     

    European Commission proceduresGoto top of the page

    Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
    26/01/2011 Centralised - Authorisation EMEA/H/C/2032 (2011)413 of 21/01/2011
    03/02/2012 Centralised - Variation EMEA/H/C/2032/IB/1
    Updated with Decision(2012)6019 of 23/08/2012
    10/05/2012 Centralised - Variation EMEA/H/C/2032/IB/2
    Updated with Decision(2012)6019 of 23/08/2012
    22/06/2012 Centralised - Variation EMEA/H/C/2032/IAin/3
    Updated with Decision(2012)6019 of 23/08/2012
    27/08/2012 Centralised - Variation - (2012)6019 of 23/08/2012