Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 20 September 2017

Indication(s)

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

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Category Value
Agency product number EMEA/H/C/003870
Orphan designation Yes
Date First Approved 03-07-2015
Type Medicinal product subject to medical prescription
Marketing authorisation holder Vanda Pharmaceuticals Ltd
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions