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Community register of orphan medicinal products


Product information

(1R, 2R)-Octanoic acid [2-(2,3-dihydro-benzo [1,4] dioxin-6-yl)-2-hydroxy-1-pyrrolidin-1-ylmethyl-ethyl]-amide-L-tartaric acid salt

EU orphan designation number: EU/3/07/514   
Active ingredient: (1R, 2R)-Octanoic acid [2-(2’,3’-dihydro-benzo [1,4] dioxin-6’-yl)-2-hydroxy-1-pyrrolidin-1-ylmethyl-ethyl]-amide-L-tartaric acid salt
Indication: Treatment of Gaucher Disease
Sponsor: Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Cerdelga on 19/01/2015 with the number EU/1/14/974

   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
06/12/2007 Orphan designation EMEA/OD/066/07 (2007)6136 of 04/12/2007