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Community register of orphan medicinal products


Product information

4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride

EU orphan designation number: EU/3/06/390   
Active ingredient: 4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride
Indication: Treatment of moderate and severe traumatic brain injury
Sponsor: vasopharm GmbH
Friedrich-Bergius-Ring 15, D-97076 Würzburg, Deutschland

   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
01/09/2006 Orphan designation EMEA/OD/035/06 (2006)3949 of 28/08/2006
27/11/2008 Change of name and/or address of sponsor