Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Docetaxel Teva   
Auth. number : EU/1/09/611
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 in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
- Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
- Docetaxel Teva 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.
- Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
- Docetaxel Teva in combination with capecitabine 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.Non-small cell lung cancer
- Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
- Docetaxel Teva 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 in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Gastric adenocarcinoma
- Docetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancer
- Docetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
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
28/01/2010 Centralised - Authorisation EMEA/H/C/1107 (2010)565 of 26/01/2010
08/06/2010 Centralised - Variation EMEA/H/C/1107/IA/4/G
Updated with Decision(2010)6028 of 26/08/2010
10/08/2010 Centralised - Variation EMEA/H/C/1107/II/3/G
31/08/2010 Centralised - Variation EMEA/H/C/1107/II/1/G, EMEA/H/C/1107/II/2/G (2010)6028 of 26/08/2010
14/02/2011 Centralised - Variation EMEA/H/C/1107/IB/5
Updated with Decision(2011)7594 of 17/10/2011
19/10/2011 Centralised - Variation (2011)7594 of 17/10/2011
09/02/2012 Centralised - Variation EMEA/H/C/1107/IB/6
Updated with Decision(2012)6423 of 11/09/2012
21/05/2012 Centralised - Variation EMEA/H/C/1107/IB/7
Updated with Decision(2012)6423 of 11/09/2012
22/06/2012 Centralised - Variation EMEA/H/C/1107/IA/8
Updated with Decision(2012)6423 of 11/09/2012
13/09/2012 Centralised - Variation (2012)6423 of 11/09/2012
12/06/2013 Centralised - Variation EMEA/H/C/1107/IB/9
Updated with Decision(2014)3823 of 03/06/2014
10/10/2013 Centralised - Variation EMEA/H/C/1107/IB/12/G
Updated with Decision(2014)3823 of 03/06/2014
19/03/2014 Centralised - Variation EMEA/H/C/1107/IB/14
Updated with Decision(2014)3823 of 03/06/2014
06/06/2014 Centralised - Variation (2014)3823 of 03/06/2014
17/07/2014 Centralised - Renewal EMEA/H/C/1107/R/13 (2014)5112 of 14/07/2014