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Community register of orphan medicinal products


Product information

Recombinant human acid sphingomyelinase

EU orphan designation number: EU/3/01/056   
Active ingredient: Recombinant human acid sphingomyelinase
Indication: Treatment of Niemann-Pick disease
Sponsor: Genzyme Europe B.V.
Gooimeer 10, 1411 DD Naarden, Nederland

   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
21/09/2001 Orphan designation EMEA/OD/004/01 (2001)2717 of 19/09/2001
12/04/2002 Transfer of orphan designation EMEA/OD/004/01/T/02 (2002)1386 of 11/04/2002
07/12/2016 Amendment of orphan designation EMA/OD/004/01 (2016)8350 of 05/12/2016