Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/12/963   
Active ingredient: Chlormethine
Indication: Treatment of cutaneous T-cell lymphoma
Sponsor: Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Ledaga on 3/03/2017 with the number EU/1/16/1171

   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
25/05/2012 Orphan designation EMA/OD/112/11 (2012)3479 of 22/05/2012
30/04/2014 Transfer of orphan designation EMA/OD/112/11/T/01 (2014)2911 of 28/04/2014
2/07/2014 Change of name and/or address of sponsor
18/12/2018 Transfer of orphan designation EMA/OD/0000002753 (2018)9016 of 14/12/2018