EU/3/15/1531: Orphan designation for the treatment of Rett syndrome

Sarizotan hydrochloride


On 28 July 2015, orphan designation (EU/3/15/1531) was granted by the European Commission to Newron Pharmaceuticals SpA, Italy, for sarizotan hydrochloride for the treatment of Rett syndrome.

Key facts

Active substance
Sarizotan hydrochloride
Intended use
Treatment of Rett syndrome
Orphan designation status
EU designation number
Date of designation
Newron Pharmaceuticals SpA
Via Lodovico Aristo
20091 Bresso
Tel. +39 0261034622
Fax +39 0261034654 or +39 0261034655

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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