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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, SE-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