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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

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, NL-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 Centralised Orphan - Designation EMEA/OD/033/00 (2001)365 of 14/02/2001
16/04/2002 Centralised Orphan - Transfer of orphan designation EMEA/OD/033/00/T/02 (2002)1409 of 15/04/2002