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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/01/078
Active ingredient: Iduronate-2-sulfatase
Indication: Treatment of Mucopolysaccharidosis, type II (Hunter Syndrome)
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 Elaprase on 08/01/2007 with the number EU/1/06/365

   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
11/12/2001 Orphan designation EMEA/OD/056/01 (2001)4111 of 11/12/2001
27/05/2005 Change of name and/or address of sponsor
03/01/2006 Transfer of orphan designation EMEA/OD/056/01/T/01 (2005)5977 of 23/12/2005
25/02/2010 Change of name and/or address of sponsor
10/01/2017 Removal of orphan designation from Community Register