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Community register of orphan medicinal products


GRANTED  

Product information

Recombinant human lysosomal acid lipase

EU orphan designation number: EU/3/10/827   
Active ingredient: Recombinant human lysosomal acid lipase
Indication: Treatment of lysosomal acid lipase deficiency
Sponsor: Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Kanuma on 28/08/2015 with the number EU/1/15/1033

   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
21/12/2010 Orphan designation EMA/OD/104/10 (2010)9540 of 17/12/2010
02/09/2011 Transfer of orphan designation EMA/OD/104/10/T/01 (2011)6292 of 30/08/2011
14/11/2014 Change of name and/or address of sponsor
22/10/2015 Transfer of orphan designation EMA/OD/104/10/T/02 (2015)7307 of 16/10/2015