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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Recombinant human alpha-N-acetylglucosaminidase

EU orphan designation number: EU/3/13/1144   
Active ingredient: Recombinant human alpha-N-acetylglucosaminidase
Indication: Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome)
Sponsor: Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

   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
25/06/2013 Orphan designation EMA/OD/035/13 (2013)3965 of 19/06/2013
14/11/2014 Change of name and/or address of sponsor
22/10/2015 Transfer of orphan designation EMA/OD/035/13/T/01 (2015)7309 of 16/10/2015