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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/03/163   
Active ingredient: 5,6,7,8-Tetrahydrobiopterin
Indication: Treatment of hyperphenylalaninemia
Sponsor: Orphanetics Pharma Entwicklungs GmbH
Innrain 66, 6020 Innsbruck, Österreich

   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
06/10/2003 Orphan designation EMEA/OD/033/03 (2003)3567 of 02/10/2003
04/01/2006 Transfer of orphan designation EMEA/OD/033/03/T/01 (2005)5972 of 23/12/2005