Hetlioz
tasimelteon
Table of contents
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.
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List item
Hetlioz : EPAR - Summary for the public (PDF/77.53 KB)
First published: 22/07/2015
Last updated: 22/07/2015 -
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Hetlioz : EPAR - Risk-management-plan summary (PDF/59.02 KB)
First published: 22/07/2015
Last updated: 22/07/2015
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
|
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 |
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. |
Product information
10/10/2022 Hetlioz - EMEA/H/C/003870 - IAIN/0032/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.