Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Paxene
Auth. number : EU/1/99/113
INN : paclitaxel
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: L01CD01 - Paclitaxel
(See WHO ATC Index)
Indication: Treatment of advanced AIDS-related Kaposi´s sarcoma (KS), metastatic carcinoma of the breast (MBC), advanced carcinoma of the ovary (AOC), metastatic carcinoma of the ovary (MOC), non-small cell lung carcinoma (NSCLC).
Marketing Authorisation Holder: Norton Healthcare Limited
Albert Basin, Royal Docks, London E16 2QJ, United Kingdom

  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
21/07/1999 Centralised - Authorisation EMEA/H/C/216 (1999)2001 of 19/07/1999
07/10/1999 Centralised - Variation EMEA/H/C/216/I/1 (1999)3196 of 05/10/1999
16/11/2000 Centralised - Variation EMEA/H/C/216/II/5 (2000)3204 of 14/11/2000
10/10/2002 Centralised - Variation EMEA/H/C/216/II/7 (2002)3835 of 08/10/2002
22/01/2004 Centralised - Variation EMEA/H/C/216/II/12 (2004)136 of 20/01/2004
30/01/2004 Centralised - Variation EMEA/H/C/216/II/10
10/03/2004 Centralised - Variation EMEA/H/C/216/II/8, 9 (2004)812 of 08/03/2004
26/03/2004 Centralised - Variation EMEA/H/C/216/IA/14
26/03/2004 Centralised - Variation EMEA/H/C/216/IA/18
31/03/2004 Centralised - Variation EMEA/H/C/216/IA/19
Updated with Decision(2004)4298 of 28/10/2004
22/04/2004 Centralised - Variation EMEA/H/C/216/IB/17
26/04/2004 Centralised - Variation EMEA/H/C/216/IB/16
19/07/2004 Centralised - Variation EMEA/H/C/216/IB/21
13/10/2004 Centralised - Variation EMEA/H/C/216/IA/30
18/10/2004 Centralised - Variation EMEA/H/C/216/IA/29
01/11/2004 Centralised - Renewal EMEA/H/C/216/R/22 (2004)4298 of 28/10/2004
25/11/2004 Centralised - Variation EMEA/H/C/216/II/23
20/12/2004 Centralised - Variation EMEA/H/C/216/II/31
23/12/2004 Centralised - Variation EMEA/H/C/216/IB/28
Updated with Decision(2005)1295 of 20/04/2005
03/01/2005 Centralised - Variation EMEA/H/C/216/II/24
22/04/2005 Centralised - Variation EMEA/H/C/216/II/25, 26 (2005)1295 of 20/04/2005
08/08/2005 Centralised - Variation EMEA/H/C/216/II/32
27/10/2005 Centralised - Variation EMEA/H/C/216/II/34 (2005)4256 of 25/10/2005
26/01/2007 Centralised - Variation EMEA/H/C/216/II/35 (2007)247 of 24/01/2007
03/05/2007 Centralised - Variation EMEA/H/C/216/N/38
Updated with Decision(2008)3086 of 19/06/2008
07/05/2007 Centralised - Variation EMEA/H/C/216/II/37
18/12/2007 Centralised - Variation EMEA/H/C/216/IA/39
13/03/2008 Centralised - Variation EMEA/H/C/216/IA/46
Updated with Decision(2008)3086 of 19/06/2008
13/03/2008 Centralised - Variation EMEA/H/C/216/IA/45
Updated with Decision(2008)3086 of 19/06/2008
13/03/2008 Centralised - Variation EMEA/H/C/216/IA/44
Updated with Decision(2008)3086 of 19/06/2008
24/06/2008 Centralised - Variation EMEA/H/C/216/II/42 (2008)3086 of 19/06/2008
04/03/2009 Centralised - Variation EMEA/H/C/216/IA/49
16/07/2009 Centralised - Renewal EMEA/H/C/216/R/47 (2009)5743 of 14/07/2009
10/12/2009 Centralised - Withdrawal (2009)9593 of 26/11/2009