Fintepla
fenfluramine
Table of contents
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.
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Fintepla : EPAR - Medicine overview (PDF/160.15 KB)
First published: 08/01/2021
EMA/694672/2020 -
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Fintepla : EPAR - Risk-management-plan summary (PDF/136.27 KB)
First published: 08/01/2021
Authorisation details
Product details | |
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Name |
Fintepla
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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 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Zogenix ROI Limited
|
Date of issue of marketing authorisation valid throughout the European Union |
18/12/2020
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Contact address |
Product information
18/12/2020 Fintepla - EMEA/H/C/003933 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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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.