Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Docetaxel Teva Pharma
Auth. number : EU/1/10/662
INN : Docetaxel
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01C - Plant alkaloids and other natural products
Chemical subgroup: L01CD - Taxanes
Chemical substance: 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

    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 is 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
    12/06/2013 Centralised - Variation EMEA/H/C/2032/IB/4
    10/10/2013 Centralised - Variation EMEA/H/C/2032/IB/7/G
    02/04/2014 Centralised - Withdrawal