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Community register of orphan medicinal products


Product information

Pegylated recombinant phenylalanine ammonia lyase

EU orphan designation number: EU/3/09/708   
Active ingredient: Pegylated recombinant phenylalanine ammonia lyase
Indication: Treatment of hyperphenylalaninaemia
Sponsor: BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland

   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
01/02/2010 Orphan designation EMEA/OD/112/09 (2010)659 of 28/01/2010
19/02/2016 Change of name and/or address of sponsor
10/08/2016 Transfer of orphan designation EMA/OD/112/09/T/01 (2016)5266 of 08/08/2016