Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Taxotere   
Auth. number : EU/1/95/002
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
TAXOTERE 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 (see section 5.1).
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE 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
TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
TAXOTERE 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
TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Gastric adenocarcinoma
TAXOTERE 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
TAXOTERE 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
29/11/1995 Centralised - Authorisation EMEA/H/C/73 (95)2849 of 27/11/1995
08/10/1996 Centralised - Variation EMEA/H/C/73/I/1 (96)2743 of 07/10/1996
04/03/1997 Centralised - Variation EMEA/H/C/73/I/3 (97)594 of 03/03/1997
26/05/1997 Centralised - Annual reassessment EMEA/H/C/73/S/5 (97)1424 of 22/05/1997
16/06/1997 Centralised - Variation EMEA/H/C/73/I/7 (97)1716 of 13/06/1997
12/11/1997 Centralised - Variation EMEA/H/C/73/II/8 (97)3398 of 10/11/1997
10/06/1998 Centralised - Variation EMEA/H/C/73/II/9 (1998)1501 of 09/06/1998
08/07/1998 Centralised - Renewal EMEA/H/C/73/S/10 (1998)1852 of 07/07/1998
20/07/1998 Centralised - Variation EMEA/H/C/73/II/11 (1998)2052 of 17/07/1998
06/08/1998 Centralised - Notification EMEA/H/C/73/N/13 (1998)2456 of 05/08/1998
22/09/1998 Centralised - Variation EMEA/H/C/73/II/12 (1998)2694 of 18/09/1998
23/06/1999 Centralised - Variation EMEA/H/C/73/II/15 (1999)1627 of 16/06/1999
30/06/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/22
07/10/1999 Centralised - Variation EMEA/H/C/73/I/18, 20 (1999)3194 of 05/10/1999
24/01/2000 Centralised - Variation EMEA/H/C/73/II/14 (2000)38 of 20/01/2000
02/08/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/27
02/08/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/28
04/09/2000 Centralised - Variation EMEA/H/C/73/II/24 (2000)2542 of 28/08/2000
18/09/2000 Centralised - Variation EMEA/H/C/73/I/26 (2000)2570 of 15/09/2000
02/01/2001 Centralised - Renewal EMEA/H/C/73/R/28 (2000)4295 of 28/12/2000
07/03/2001 Centralised - Variation EMEA/H/C/73/II/30 (2001)911 of 03/05/2001
24/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/33
02/08/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/31
14/08/2001 Centralised - Variation EMEA/H/C/73/I/32 (2001)2116 of 13/08/2001
19/04/2002 Centralised - Variation EMEA/H/C/73/II/34 (2002)1542 of 16/04/2002
25/04/2002 Centralised - Variation EMEA/H/C/73/II/35 (2002)1586 of 23/04/2002
21/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/39
21/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/38
16/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/41
13/01/2003 Centralised - Variation EMEA/H/C/73/II/36, 40 (2003)259 of 09/01/2003
28/01/2003 Centralised - Variation EMEA/H/C/73/II/37 (2003)402 of 24/01/2003
23/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/42
16/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/43
26/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/46
26/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/45
23/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/47
05/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/49
05/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/48
05/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/50
18/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/I/51
10/10/2003 Centralised - Variation EMEA/H/C/73/II/44 (2003)3733 of 08/10/2003
25/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/55
01/06/2004 Centralised - Variation EMEA/H/C/73/II/53 (2004)1985 of 26/05/2004
07/06/2004 Centralised - Variation EMEA/H/C/73/IB/56
Updated with Decision(2004)4192 of 20/10/2004
07/06/2004 Centralised - Variation EMEA/H/C/73/IB/57
Updated with Decision(2004)4192 of 20/10/2004
22/10/2004 Centralised - Variation EMEA/H/C/73/II/52 (2004)4192 of 20/10/2004
24/12/2004 Centralised - Variation EMEA/H/C/73/II/58 (2004)5621 of 22/12/2004
07/01/2005 Centralised - Variation EMEA/H/C/73/II/54 (2005)15 of 05/01/2005
18/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IA/60
27/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/59
14/06/2005 Centralised - Variation EMEA/H/C/73/II/61 (2005)1799 of 10/06/2005
30/06/2005 Centralised - Variation EMEA/H/C/73/II/62 (2005)2086 of 28/06/2005
28/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IB/65
18/11/2005 Centralised - Variation EMEA/H/C/73/II/66 (2005)4509 of 15/11/2005
26/01/2006 Centralised - Renewal EMEA/H/C/73/R/63 (2006)204 of 24/01/2006
06/02/2006 Centralised - Notification EMEA/H/C/73/N/68
Updated with Decision(2006)1824 of 27/04/2006
22/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IB/69
04/05/2006 Centralised - Variation EMEA/H/C/73/II/67 (2006)1824 of 27/04/2006
06/07/2006 Centralised - Variation EMEA/H/C/73/II/71 (2006)3139 of 04/07/2006
13/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IA/76
13/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/77
26/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IB/75
08/08/2006 Centralised - Variation EMEA/H/C/73/II/72 (2006)3633 of 04/08/2006
27/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/73
27/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/74
25/10/2006 Centralised - Variation EMEA/H/C/73/II/70 (2006)5154 of 23/10/2006
12/01/2007 Centralised - Notification EMEA/H/C/73/N/78
Updated with Decision(2007)5848 of 23/11/2007
03/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/79
09/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IA/82
27/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/81
27/11/2007 Centralised - Variation EMEA/H/C/73/II/80 (2007)5848 of 23/11/2007
16/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IA/84
28/11/2008 Centralised - Variation EMEA/H/C/73/II/85 (2008)7694 of 26/11/2008
27/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IB/88
29/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/89
02/12/2009 Centralised - Variation EMEA/H/C/73/X/86 (2009)9776 of 30/11/2009
23/12/2009 Centralised - Variation EMEA/H/C/73/II/87 (2009)10703 of 21/12/2009
05/03/2010 Centralised - Variation EMEA/H/C/73/IB/93
Updated with Decision(2010)2838 of 27/04/2010
17/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IB/94
27/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/II/91
29/04/2010 Centralised - Variation EMEA/H/C/73/II/92 (2010)2838 of 27/04/2010
27/05/2010 Centralised - Variation EMEA/H/C/73/IG/4/G
Updated with Decision(2010)4667 of 01/07/2010
01/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IB/95
05/07/2010 Centralised - Variation EMEA/H/C/73/II/90 (2010)4667 of 01/07/2010
21/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/73/IG/24/G
04/05/2011 Centralised - Notification EMEA/H/C/73/N/96
Updated with Decision(2011)6934 of 22/09/2011
07/07/2011 Centralised - Variation EMEA/H/C/73/IG/91
Updated with Decision(2011)6934 of 22/09/2011
27/09/2011 Centralised - Variation (2011)6934 of 22/09/2011
04/11/2011 Centralised - Variation EMEA/H/C/73/II/97, 98 (2011)7940 of 27/10/2011
19/12/2011 Centralised - Variation EMEA/H/C/73/IB/99/G
Updated with Decision(2012)764 of 06/02/2012
09/01/2012 Centralised - Variation EMEA/H/C/73/IB/101/G
Updated with Decision(2012)5276 of 20/07/2012
08/02/2012 Centralised - Variation EMEA/H/C/73/II/100 (2012)764 of 06/02/2012
11/06/2012 Centralised - Variation EMEA/H/C/73/IB/107
Updated with Decision(2012)5276 of 20/07/2012
24/07/2012 Centralised - Variation (2012)5276 of 20/07/2012
21/08/2012 Centralised - Notification EMEA/H/C/73/N/108
Updated with Decision(2014)784 of 06/02/2014
21/02/2013 Centralised - Variation EMEA/H/C/73/II/110
Updated with Decision(2014)784 of 06/02/2014
04/03/2013 Centralised - Variation EMEA/H/C/73/IA/11/G
Updated with Decision(2014)784 of 06/02/2014
27/06/2013 Centralised - Variation EMEA/H/C/73/II/112/G
Updated with Decision(2014)784 of 06/02/2014
18/12/2013 Centralised - Variation EMEA/H/C/73/II/114
Updated with Decision(2014)784 of 06/02/2014
10/02/2014 Centralised - Yearly update (2014)784 of 06/02/2014
25/04/2014 Centralised - Variation EMEA/H/C/73/II/115