On 2 October 2003, orphan designation (EU/3/03/163) was granted by the European Commission to Prof. Dr. A. A. Roscher, Germany, for 5,6,7,8 tetrahydrobiopterin for the treatment of hyperphenylalaninemia.
The sponsorship was transferred to Orphanetics Pharma Entwicklungs GmbH, Austria, in December 2005.
Treatment of hyperphenylalaninaemia
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Documents related to this orphan designation evaluation
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: