EU/3/02/111: Orphan designation for the treatment of non-ketotic hyperglycinaemia

Benzoic acid, sodium salt

Table of contents


On 11 September 2002, orphan designation (EU/3/02/111) was granted by the European Commission to Ethicare GmbH, Germany, for benzoic acid, sodium salt for the treatment of non-ketotic hyperglycinaemia.

The sponsorship was transferred to Lucane Pharma SA, France, in November 2016.

The sponsorship was transferred to Ethicare GmbH in February 2020.


Key facts

Active substance
Benzoic acid, sodium salt
Intended use
Treatment of non-ketotic hyperglycinaemia
Orphan designation status
EU designation number
Date of designation

Ethicare GmbH 
Wiechertstrasse 3 
45721 Haltern Am See 
North Rhine-Westphalia 
Tel. +49 170 187 9410

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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