EU/3/19/2157

About

On 24 April 2019, orphan designation (EU/3/19/2157) was granted by the European Commission to Dipharma B.V., the Netherlands, for sodium benzoate, sodium phenylacetate for the treatment of ornithine transcarbamylase deficiency.

Key facts

Active substance
  • Sodium benzoate
  • Sodium phenylacetate
Disease / condition
Treatment of ornithine transcarbamylase deficiency
Date of first decision
24/04/2019
Outcome
Positive
EU designation number
EU/3/19/2157

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

Dipharma B.V.
Prins Bernhardplein 200
1097 JB Amsterdam
Netherlands
Tel. +41 9160 11713
E-mail: regulatory@dipharma-group.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

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