EU/3/10/821

About

On 17 December 2010, orphan designation (EU/3/10/821) was granted by the European Commission to Cytonet GmbH & Co. KG, Germany, for human heterologous liver cells (for infusion) for the treatment of carbamoyl-phosphate synthase-1 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 carbamoyl-phosphate synthase-1 deficiency
Date of decision
17/12/2010
Outcome
Positive
Orphan decision number
EU/3/10/821

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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

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.

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