Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/05/273   
Active ingredient: Ambrisentan
Indication: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Sponsor: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Volibris on 21/04/2008 with the number EU/1/08/451

   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
15/04/2005 Orphan designation EMEA/OD/103/04 (2005)1199 of 11/04/2005
12/08/2005 Transfer of orphan designation EMEA/OD/103/04/T/01 (2005)3177 of 10/08/2005
03/10/2006 Transfer of orphan designation EMEA/OD/103/04/T/02 (2006)4399 of 29/09/2006
04/02/2014 Change of name and/or address of sponsor