Pharmaceuticals - Community Register

  

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: 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 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 metastatic prostate cancer.

Gastric adenocarcinoma
Docetaxel Winthrop 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 Winthrop 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: Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony CEDEX, France

  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
24/04/2007 Centralised - Authorisation EMEA/H/C/808 (2007)1860 of 20/04/2007
16/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/808/IA/4
24/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/808/II/2
24/10/2007 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/808/IA/6
29/08/2008 Centralised - Variation
27/11/2008 Centralised - Variation EMEA/H/C/808/II/7 (2008)7602 of 25/11/2008
27/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/808/IB/10
06/10/2009 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/808/IB/16
29/04/2010 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/808/IG/24/G
28/04/2011 Centralised - Notification 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 - Notification 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
Updated with Decision(2014)641 of 31/01/2014
27/06/2013 Centralised - Variation EMEA/H/C/808/II/37/G
Updated with Decision(2014)641 of 31/01/2014
18/12/2013 Centralised - Variation EMEA/H/C/808/II/39
Updated with Decision(2014)641 of 31/01/2014
04/02/2014 Centralised - Yearly update (2014)641 of 31/01/2014
25/04/2014 Centralised - Variation EMEA/H/C/808/II/40