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Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/04/199   
Active ingredient: Tetrahydrobiopterin
Indication: Treatment of hyperphenylalaninemia
Sponsor: BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Kuvan on 02/12/2008 with the number EU/1/08/481

   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
14/06/2004 Orphan designation EMEA/OD/077/03 (2004)2088 of 08/06/2004
09/03/2005 Transfer of orphan designation EMEA/OD/077/03/T/01 (2005)507 of 07/03/2005
23/08/2006 Transfer of orphan designation EMEA/OD/077/03/T/02 (2006)3837 of 21/08/2006
20/09/2007 Transfer of orphan designation EMEA/OD/077/03/T/03 (2007)4378 of 17/09/2007
11/03/2011 Transfer of orphan designation EMEA/OD/077/03/T/04 (2011)1685 of 09/03/2011
08/12/2015 Transfer of orphan designation EMA/OD/077/03/T/05 (2015)8951 of 04/12/2015