EU/3/03/163: Orphan designation for the treatment of hyperphenylalaninaemia

5,6,7,8-Tetrahydrobiopterin

Table of contents

Overview

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.

Key facts

Active substance
5,6,7,8-Tetrahydrobiopterin
Intended use
Treatment of hyperphenylalaninaemia
Orphan designation status
Positive
EU designation number
EU/3/03/163
Date of designation
02/10/2003
Sponsor
Orphanetics Pharma Entwicklungs GmbH
Innrain 66
6020 Innsbruck
Austria
Telephone: +43 512 57 98 23 42 90
Telefax: +43 512 57 98 23 42 91
E-mail: barbara.brunnhuber@orphanetics.com

Documents related to this orphan designation evaluation

Patients' organisations

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:

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