Fintepla

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fenfluramine

Authorised
This medicine is authorised for use in the European Union.

Overview

Fintepla is a medicine used in addition to other epilepsy medicines to treat patients from the age of 2 years who have Dravet syndrome, a type of epilepsy that begins in childhood and can continue into adulthood.

Dravet syndrome is rare, and Fintepla was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 December 2013.

Fintepla contains the active substance fenfluramine.

This EPAR was last updated on 08/01/2021

Authorisation details

Product details
Name
Fintepla
Agency product number
EMEA/H/C/003933
Active substance
Fenfluramine hydrochloride
International non-proprietary name (INN) or common name
fenfluramine
Therapeutic area (MeSH)
Epilepsies, Myoclonic
Anatomical therapeutic chemical (ATC) code
N03
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.

OrphanOrphan

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
Zogenix ROI Limited
Date of issue of marketing authorisation valid throughout the European Union
18/12/2020
Contact address

Trinity House
Charleston Road Ranelagh
Dublin 6
D06 C8X4
Ireland

Product information

18/12/2020 Fintepla - EMEA/H/C/003933 -

Contents

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Pharmacotherapeutic group

Antiepileptics

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.

Assessment history

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