Hetlioz

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tasimelteon

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

Overview

This is a summary of the European public assessment report (EPAR) for Hetlioz. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Hetlioz.

For practical information about using Hetlioz, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 11/10/2022

Authorisation details

Product details
Name
Hetlioz
Agency product number
EMEA/H/C/003870
Active substance
tasimelteon
International non-proprietary name (INN) or common name
tasimelteon
Therapeutic area (MeSH)
Sleep Disorders, Circadian Rhythm
Anatomical therapeutic chemical (ATC) code
N05CH
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
Vanda Pharmaceuticals Netherlands B.V.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
03/07/2015
Contact address

Vanda Pharmaceuticals Netherlands B.V.
Basisweg 10
1043 AP Amsterdam
NETHERLANDS

Product information

10/10/2022 Hetlioz - EMEA/H/C/003870 - IAIN/0032/G

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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

Psycholeptics

Therapeutic indication

Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.

Assessment history

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