Hetlioz

RSS

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 20/09/2017

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
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
Marketing-authorisation holder
Vanda Pharmaceuticals Ltd
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
03/07/2015
Contact address
25 Old Broad Street
Level 21A
London EC2N 1HQ
United Kingdom

Product information

06/07/2017 Hetlioz - EMEA/H/C/003870 - II/0008

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.

You are therefore advised to be selective about which sections or pages you wish to print.

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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