EU/3/13/1219: Orphan designation for the treatment of Dravet syndrome

Fenfluramine hydrochloride


Fenfluramine hydrochloride has been authorised in the EU as Fintepla since 18 December 2020.

On 18 December 2013, orphan designation (EU/3/13/1219) 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 and to Zogenix ROI Limited, Germany, in May 2019. 

Key facts

Active substance
Fenfluramine hydrochloride
Intended use
Treatment of Dravet syndrome
Orphan designation status
EU designation number
Date of designation

Zogenix ROI Limited
Trinity House
Charleston Road
Dublin 6 
D06 C8X4

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Fintepla at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Documents related to this orphan designation evaluation

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.

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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