Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/12/1025   
Active ingredient: Metreleptin
Indication: Treatment of Berardinelli-Seip syndrome
Sponsor: Aegerion Pharmaceuticals B.V.
Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Myalepta on 30/07/2018 with the number EU/1/18/1276

   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
19/07/2012 Orphan designation EMA/OD/036/12 (2012)5149 of 17/07/2012
14/02/2014 Transfer of orphan designation EMA/OD/036/12/T/01 (2014)1033 of 12/02/2014
15/04/2014 Transfer of orphan designation EMA/OD/036/12/T/02 (2014)2622 of 11/04/2014
17/06/2014 Change of name and/or address of sponsor
27/03/2015 Transfer of orphan designation EMA/OD/036/12/T/03 (2015)2216 of 25/03/2015
4/12/2017 Transfer of orphan designation EMA/OD/036/12/T/04 (2017)8247 of 30/11/2017
5/06/2018 Other procedure