Navigation path

Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Alpha-Galactosidase A

EU orphan designation number: EU/3/00/002
Active ingredient: Alpha-Galactosidase A
Indication: Treatment of Fabry disease
Sponsor: Shire Human Genetic Therapies AB
Rinkebyvägen 11B, 182 36 Danderyd, Sverige
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Replagal on 03/08/2001 with the number EU/1/01/189

   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
28/08/2000 Orphan designation EMEA/OD/007/00 (2000)2479 of 08/08/2000
27/05/2005 Change of name and/or address of sponsor
09/11/2010 Change of name and/or address of sponsor
03/08/2011 Removal of orphan designation from Community Register