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- Docetaxel Winthrop
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Docetaxel Winthrop
This product is authorized under a different brandname in the EU in the folowing languages:
- Docétaxel Winthrop (FR)
|
| Auth. number : | EU/1/07/384 |
| 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 Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: - operable node‑positive breast cancer - operable node-negative breast cancer For patients with operable node‑negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Winthrop 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 Winthrop 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 Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Winthrop 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 Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Docetaxel Winthrop 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 Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metas |
| Marketing Authorisation Holder: | Aventis Pharma S.A.
20 avenue Raymond Aron, F-92160 Antony CEDEX, France |
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 procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 24/04/2007 | Centralised - Authorisation | EMEA/H/C/808 | (2007)1860 of 20/04/2007 | |||
| 16/08/2007 | Centralised - Variation | EMEA/H/C/808/IA/4 | ||||
| 24/10/2007 | Centralised - Variation | EMEA/H/C/808/II/2 | ||||
| 24/10/2007 | Centralised - Variation | EMEA/H/C/808/II/3 | ||||
| 27/11/2007 | Centralised - Variation | EMEA/H/C/808/II/1 | (2007)5845 of 23/11/2007 | |||
| 16/04/2008 | Centralised - Variation | EMEA/H/C/808/IA/6 | ||||
| 27/11/2008 | Centralised - Variation | EMEA/H/C/808/II/7 | (2008)7602 of 25/11/2008 | |||
| 27/05/2009 | Centralised - Variation | EMEA/H/C/808/IB/10 | ||||
| 06/10/2009 | Centralised - Variation | EMEA/H/C/808/II/11 | ||||
| 02/12/2009 | Centralised - Variation | EMEA/H/C/808/X/8 | (2009)9777 of 30/11/2009 | |||
| 22/12/2009 | Centralised - Variation | EMEA/H/C/808/II/9 | (2009)10594 of 18/12/2009 | |||
| 09/03/2010 | Centralised - Variation | EMEA/H/C/808/IB/15 | ||||
| Updated with Decision(2010)3080 of 05/05/2010 | ||||||
| 25/03/2010 | Centralised - Variation | EMEA/H/C/808/IB/16 | ||||
| 29/04/2010 | Centralised - Variation | EMEA/H/C/808/II/13 | ||||
| 07/05/2010 | Centralised - Variation | EMEA/H/C/808/II/14 | (2010)3080 of 05/05/2010 | |||
| 27/05/2010 | Centralised - Variation | EMEA/H/C/808/IA/4/G | ||||
| Updated with Decision(2010)4811 of 06/07/2010 | ||||||
| 06/07/2010 | Centralised - Variation | EMEA/H/C/808/IB/17 | ||||
| 08/07/2010 | Centralised - Variation | EMEA/H/C/808/II/12 | (2010)4811 of 06/07/2010 | |||
| 21/10/2010 | Centralised - Variation | EMEA/H/C/808/IG/24/G | ||||
| 28/04/2011 | Centralised - Variation | EMEA/H/C/808/N/18 | ||||
| Updated with Decision(2011)6646 of 19/09/2011 | ||||||
| 07/07/2011 | Centralised - Variation | EMEA/H/C/808/IG/91 | ||||
| Updated with Decision(2011)6646 of 19/09/2011 | ||||||
| 22/09/2011 | Centralised - Variation | - | (2011)6646 of 19/09/2011 | |||
| 26/10/2011 | Centralised - Variation | EMEA/H/C/808/II/19, 20 | (2011)7786 of 24/10/2011 | |||
| 02/02/2012 | Centralised - Variation | EMEA/H/C/808/II/22 | (2012)657 of 31/01/2012 | |||
| 12/03/2012 | Centralised - Renewal | EMEA/H/C/808/R/21 | (2012)1631 of 08/03/2012 | |||
| 02/08/2012 | Centralised - Variation | EMEA/H/C/808/IB/34/G | ||||
| Updated with Decision(2012)8002 of 31/10/2012 | ||||||
| 21/08/2012 | Centralised - Variation | EMEA/H/C/808/N/33 | ||||
| Updated with Decision(2012)8002 of 31/10/2012 | ||||||
| 06/11/2012 | Centralised - Variation | - | (2012)8002 of 31/10/2012 | |||
| 21/02/2013 | Centralised - Variation | EMEA/H/C/808/II/36 | ||||