EU/3/06/390: Orphan designation for the treatment of moderate and severe traumatic brain injury

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

Table of contents


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.

Key facts

Active substance
4-Amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride (ronopterin)
Intended use
Treatment of moderate and severe traumatic brain injury
Orphan designation status
EU designation number
Date of designation

veriNOS operations GmbH
Friedrich-Bergius-Ring 15
97076 Wuerzburg

Update history

August 2023The sponsor’s name was changed from Vasopharm GmbH to veriNOS operations GmbH in August 2023.

Documents related to this orphan designation evaluation

Patients' organisations

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:

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