EU/3/07/470
About
On 14 September 2007, orphan designation (EU/3/07/470) was granted by the European Commission to Cytonet GmbH & Co. KG, Germany, for human heterologous liver cells (for infusion) for the treatment of ornithine-transcarbamylase deficiency
A marketing authorisation for this medicine (Heparesc) was refused on 22 October 2015.
The sponsorship was transferred to Promethera Biosciences, Belgium, in June 2016.
Key facts
Active substance |
Human heterologous liver cells (for infusion)
|
Disease / condition |
Treatment of ornithine-transcarbamylase deficiency
|
Date of first decision |
14/09/2007
|
Outcome |
Positive
|
EU designation number |
EU/3/07/470
|
Sponsor's contact details
Promethera Biosciences
11 Rue Granbonpré
1435 Mont-Saint-Guibert
Belgium
Tel. +32 (0)10 394 304
Fax +32 (0)10 394 301
E-mail: contact@promethera.com
11 Rue Granbonpré
1435 Mont-Saint-Guibert
Belgium
Tel. +32 (0)10 394 304
Fax +32 (0)10 394 301
E-mail: contact@promethera.com
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.