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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Sitaxentan sodium

EU orphan designation number: EU/3/04/234
Active ingredient: Sitaxentan sodium
Indication: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Sponsor: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Thelin on 10/08/2006 with the number EU/1/06/353

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/10/2004 Orphan designation EMEA/OD/031/04 (2004)4225 of 21/10/2004
12/08/2005 Transfer of orphan designation EMEA/OD/031/04/T/01 (2005)2653 of 13/07/2005
30/09/2010 Transfer of orphan designation EMEA/OD/031/04/T/02 (2010)6801 of 28/09/2010
4/03/2013 Removal of orphan designation from Community Register