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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Recombinant human bile salt-stimulated lipase

EU orphan designation number: EU/3/04/257
Active ingredient: Recombinant human bile salt-stimulated lipase
Indication: Treatment of cystic fibrosis
Sponsor: Arexis AB
Drottninggatan 98, 111 60 Stockholm, Sverige

   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
31/01/2005 Orphan designation EMEA/OD/023/04 (2005)240 of 26/01/2005
10/02/2012 Change of name and/or address of sponsor EMEA/OD/023/04
19/02/2016 Removal of orphan designation from Community Register