Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/05/282   
Active ingredient: Miltefosine
Indication: Treatment of Acanthamoeba keratitis
Sponsor: Orpha-Devel Handels und Vertriebs GmbH
Wintergrasse 85/1B, 3002 Purkersdorf, Österreich

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
31/05/2005 Orphan designation EMEA/OD/007/05 (2005)1661 of 27/05/2005
29/05/2007 Change of name and/or address of sponsor
12/07/2007 Transfer of orphan designation EMEA/OD/007/05/T/01 (2007)3434 of 10/07/2007
10/12/2008 Transfer of orphan designation EMEA/OD/007/05/T/02 (2008)8160 of 04/12/2008
14/12/2015 Transfer of orphan designation EMA/OD/007/05/T/03 (2015)8952 of 04/12/2015