Navigation path

Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Recombinant human acid alpha-glucosidase

EU orphan designation number: EU/3/00/018
Active ingredient: Recombinant human acid alpha-glucosidase
Indication: Treatment of Glycogen Storage Disease type II (Pompe's disease)
Sponsor: Genzyme Europe B.V.
Gooimeer 10, 1411 DD Naarden, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Myozyme on 29/03/2006 with the number EU/1/06/333

   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
22/02/2001 Orphan designation EMEA/OD/033/00 (2001)365 of 14/02/2001
16/04/2002 Transfer of orphan designation EMEA/OD/033/00/T/02 (2002)1409 of 15/04/2002
31/03/2016 Removal of orphan designation from Community Register