This medicine is authorised for use in the European Union.


Fintepla is a medicine used in addition to other epilepsy medicines to treat patients from 2 years of age who have Dravet syndrome or Lennox-Gastaut syndrome, types of epilepsy that begin in childhood and continue into adulthood.

These conditions are rare, and Fintepla was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the Agency’s website (Dravet syndrome: 18 December 2013; Lennox-Gastaut syndrome: 27 February 2017).  

Fintepla contains the active substance fenfluramine.

This EPAR was last updated on 20/04/2023

Authorisation details

Product details
Agency product number
Active substance
Fenfluramine hydrochloride
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Epilepsies, Myoclonic
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
UCB Pharma S.A.  
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Allée de la Recherche 60
B-1070 Bruxelles

Product information

12/04/2023 Fintepla - EMEA/H/C/003933 - T/0020

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Treatment of seizures associated with Dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older.

Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

Assessment history

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