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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, NL-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