EU/3/17/1836: Orphan designation for the treatment of Lennox-Gastaut syndrome

Fenfluramine hydrochloride



On 27 February 2017, orphan designation (EU/3/17/1836) was granted by the European Commission to Zogenix International Limited, United Kingdom, for fenfluramine hydrochloride for the treatment of Lennox-Gastaut syndrome.

Fenfluramine hydrochloride treatment of Lennox-Gastaut syndrome has been authorised in the EU as Fintepla since 24 January 2023.

Key facts

Active substance
Fenfluramine hydrochloride
Intended use
Treatment of Lennox-Gastaut syndrome
Orphan designation status
EU designation number
Date of designation

UCB Pharma
Allee De La Recherche 60
1070 Anderlecht
Brussels-Capital Region

Review of designation

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

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

More information is available in the orphan medicine assessment report.

Update history

April 2023The sponsorship was transferred from Zogenix ROI Limited, Irealnd to UCB Pharma, Belgium.
May 2019The sponsorship was transferred to Zogenix ROI Limited, Germany. 
November 2018The sponsorship was transferred to Zogenix GmbH, Germany.

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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