On 28 August 2006, orphan designation (EU/3/06/390) was granted by the European Commission to vasopharm BIOTECH GmbH, Germany, for 4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride for the treatment of moderate and severe traumatic brain injury (ronopterin).
This medicine is now known as ronopterin.
4-Amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride (ronopterin)
Treatment of moderate and severe traumatic brain injury
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|August 2023||The sponsor’s name was changed from Vasopharm GmbH to veriNOS operations GmbH in August 2023.|
Documents related to this orphan designation evaluation
EU/3/06/390: Public summary of positive opinion for orphan designation of 4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride for the treatment of moderate and severe traumatic brain injury (PDF/118.36 KB)
First published: 24/02/2009
Last updated: 27/05/2011
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
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: