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



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
Intended use
Treatment of neonatal encephalopathy
Orphan designation status
EU designation number
Date of designation
Mithra Pharmaceuticals S.A.
Rue Saint-Georges 5-7
4000 Liège
Tel. +32 4 349 28 22

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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