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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, A-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