Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Onsenal
Auth. number : EU/1/03/259
INN : Celecoxib
Orphan status based on designation EU/3/01/070 added on 22/10/2003
Orphan status based on designation EU/3/01/070 removed or expired on 24/03/2011
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX33 - Celecoxib
(See WHO ATC Index)
Indication: reduction of the number of adenomatous intestinal polyps in familial polyposis, as an adjunct to surgery and further endoscopic surveillance
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
22/10/2003 Centralised - Authorisation EMEA/H/C/466 (2003)3938 of 17/10/2003
04/05/2004 Centralised - Variation EMEA/H/C/466/II/1 (2004)1681 of 22/04/2004
02/07/2004 Centralised - Variation EMEA/H/C/466/IA/2
Updated with Decision(2005)479 of 23/02/2005
11/11/2004 Centralised - Variation EMEA/H/C/466/IB/3
Updated with Decision(2005)479 of 23/02/2005
25/02/2005 Centralised - Variation (2005)479 of 23/02/2005
06/06/2005 Centralised - Annual reassessment EMEA/H/C/466/S/4 (2005)1713 of 02/06/2005
07/10/2005 Referral EMEA/H/C/466/A-18/633 (2005)3799 of 05/10/2005
28/03/2006 Centralised - Annual reassessment EMEA/H/C/466/S/6
05/06/2006 Centralised - Variation EMEA/H/C/466/IA/8
05/06/2006 Centralised - Variation EMEA/H/C/466/IA/7
30/06/2006 Centralised - Variation EMEA/H/C/466/IA/11
Updated with Decision(2007)835 of 06/03/2007
13/07/2006 Centralised - Variation EMEA/H/C/466/IB/10
08/03/2007 Centralised - Variation (2007)835 of 06/03/2007
27/07/2007 Centralised - Annual reassessment EMEA/H/C/466/S/12 (2007)3672 of 24/07/2007
05/11/2007 Centralised - Variation EMEA/H/C/466/IA/19
05/11/2007 Centralised - Variation EMEA/H/C/466/IA/18
13/11/2007 Centralised - Variation EMEA/H/C/466/IA/16
16/11/2007 Centralised - Variation EMEA/H/C/466/IB/17
10/01/2008 Centralised - Variation EMEA/H/C/466/IB/15
29/01/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/466/T/14 (2008)395 of 25/01/2008
22/05/2008 Centralised - Annual reassessment EMEA/H/C/466/S/20 (2008)2159 of 20/05/2008
25/06/2008 Centralised - Variation EMEA/H/C/466/IA/24
Updated with Decision(2008)6213 of 20/10/2008
25/06/2008 Centralised - Variation EMEA/H/C/466/IA/23
Updated with Decision(2008)6213 of 20/10/2008
22/10/2008 Centralised - Renewal EMEA/H/C/466/R/21 (2008)6213 of 20/10/2008
19/03/2009 Centralised - Variation EMEA/H/C/466/II/25 (2009)2066 of 17/03/2009
03/09/2009 Centralised - Variation EMEA/H/C/466/IB/27
16/10/2009 Centralised - Annual reassessment EMEA/H/C/466/S/26 (2009)8007 of 14/10/2009
10/05/2010 Centralised - Variation EMEA/H/C/466/IA/30/G
15/06/2010 Centralised - Variation EMEA/H/C/466/IB/31/G
21/06/2010 Centralised - Annual reassessment EMEA/H/C/466/S/29 (2010)4215 of 17/06/2010
30/07/2010 Centralised - Variation EMEA/H/C/466/II/28 (2010)5398 of 28/07/2010
29/03/2011 Centralised - Withdrawal (2011)2106 of 24/03/2011