Basic Information
Hetlioz
Regulatory Information
EMEA/H/C/003870
Authorised
July 3, 2015
April 23, 2015
9
October 11, 2022
Company Information
Netherlands
Vanda Pharmaceuticals Netherlands B.V. Basisweg 10 1043 AP Amsterdam
Vanda Pharmaceuticals Netherlands BV
Drug Classification
Orphan Medicine
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Overview Summary
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.