On 16 January 2014, orphan designation (EU/3/14/1219) was granted by the European Commission to Brabant Pharma Limited, United Kingdom, for fenfluramine hydrochloride for the treatment of Dravet syndrome.

In December 2015, Brabant Pharma Limited changed name to Zogenix International Limited.

The sponsorship was transferred to Zogenix GmbH, Germany, in November 2018.

The sponsorship was transferred to Zogenix ROI Limited, Germany, in May 2019. 

Key facts

Active substance
Fenfluramine hydrochloride
Disease / condition
Treatment of Dravet syndrome
Date of first decision
EU designation number

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

Zogenix ROI Limited
Trinity House
Charleston Road
Dublin 6 
D06 C8X4

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.

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