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.
Treatment of Dravet syndrome
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Review of designation
Documents related to this orphan designation evaluation
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: