Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Thelin
Auth. number : EU/1/06/353
INN : Sitaxentan sodium
Orphan status based on designation EU/3/04/234 added on 11/08/2006
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C02 - Antihypertensives
Pharmacological subgroup: C02K - Other antihypertensives
Chemical subgroup: C02KX - Other antihypertensives
Chemical substance: C02KX03 - Sitaxentan
(See WHO ATC Index)
Indication: Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.
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
11/08/2006 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/679 (2006)3722 of 10/08/2006
11/08/2006 Centralised - Authorisation EMEA/H/C/679 (2006)3721 of 10/08/2006
27/09/2006 Corrigendum EMEA/H/C/679 (2006)3722 corr of 26/09/2006
13/10/2006 Centralised - Notification EMEA/H/C/679/N/2
Updated with Decision(2007)2262 of 22/05/2007
23/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/II/1
11/04/2007 Centralised - Variation EMEA/H/C/679/IA/7
Updated with Decision(2008)157 of 11/01/2008
25/05/2007 Centralised - Variation EMEA/H/C/679/II/3 (2007)2261 of 22/05/2007
25/05/2007 Centralised - Variation EMEA/H/C/679/II/3 (2007)2262 of 22/05/2007
31/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/II/6
31/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/II/4
06/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IA/12
18/06/2007 Centralised - Variation EMEA/H/C/679/IB/11
Updated with Decision(2008)157 of 11/01/2008
24/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/II/9
27/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/II/10
15/01/2008 Centralised - Variation (2008)157 of 11/01/2008
15/02/2008 Centralised - Variation EMEA/H/C/679/IA/13
Updated with Decision(2008)5597 of 26/09/2008
30/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IA/14
30/09/2008 Centralised - Variation (2008)5597 of 26/09/2008
29/10/2008 Centralised - Variation EMEA/H/C/679/IA/17
Updated with Decision(2009)3027 of 16/04/2009
29/01/2009 Centralised - Variation EMEA/H/C/679/II/16 (2009)593 of 27/01/2009
21/04/2009 Centralised - Variation EMEA/H/C/679/II/15 (2009)3060 of 17/04/2009
21/04/2009 Centralised - Variation EMEA/H/C/679/II/15 (2009)3027 of 16/04/2009
06/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/II/20
16/07/2009 Centralised - Variation EMEA/H/C/679/II/19 (2009)5760 of 14/07/2009
18/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IA/22
03/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IB/21
11/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IA/24
25/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IB/23
28/09/2009 Centralised - Variation EMEA/H/C/679/IA/25
Updated with Decision(2009)10697 of 21/12/2009
28/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IA/28
28/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IA/27
28/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IA/26
24/12/2009 Centralised - Variation EMEA/H/C/679/II/18 (2009)10697 of 21/12/2009
04/02/2010 Centralised - Notification EMEA/H/C/679/N/30
Updated with Decision(2010)4781 of 05/07/2010
07/07/2010 Centralised - Variation EMEA/H/C/679/II/29 (2010)4782 of 05/07/2010
08/07/2010 Centralised - Variation EMEA/H/C/679/II/29 (2010)4781 of 05/07/2010
26/07/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/679/T/31 (2010)5217 of 22/07/2010
22/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/679/IA/32
11/01/2011 Centralised - Withdrawal (2011)74 of 06/01/2011