Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/11/914   
Active ingredient: Smilagenin
Indication: Treatment of amyotrophic lateral sclerosis
Sponsor: Quality Regulatory Clinical Ireland Limited
21 Priory Office Park, Stillorgan, County Dublin, A94 F660, Ireland

   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
29/09/2011 Orphan designation EMA/OD/043/11 (2011)7047 of 27/09/2011
18/10/2013 Transfer of orphan designation EMA/OD/043/11/T/01 (2013)6966 of 16/10/2013
14/02/2019 Transfer of orphan designation EMA/OD/0000003741 (2019)1374 of 12/02/2019