EU/3/17/1865: Orphan designation for the treatment of neonatal encephalopathy

Estetrol

Overview

On 20 April 2017, orphan designation (EU/3/17/1865) was granted by the European Commission to Mithra Pharmaceuticals S.A., Belgium, for estetrol for the treatment of neonatal encephalopathy.

Key facts

Active substance
Estetrol
Intented use
Treatment of neonatal encephalopathy
Orphan designation status
Positive
EU designation number
EU/3/17/1865
Date of designation
20/04/2017
Sponsor
Mithra Pharmaceuticals S.A.
Rue Saint-Georges 5-7
4000 Liège
Belgium
Tel. +32 4 349 28 22
E-mail: info@mithra.com

Review of designation

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

Documents related to this orphan designation evaluation

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.

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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