Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Hetlioz   
Auth. number : EU/1/15/1008
Active substance : tasimelteon
Orphan market exclusivity for "Treatment of non-24-hour sleep-wake disorders in blind people with no light perception" (based on designation EU/3/10/841) started on 07/07/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 07/07/2025
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05C - Hypnotics and sedatives
Chemical subgroup: N05CH - Melatonin receptor agonists
Chemical substance: N05CH03 - Tasimelteon
(See WHO ATC Index)
Indication: HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Marketing Authorisation Holder: Vanda Pharmaceuticals Limited
25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
07/07/2015 Centralised - Authorisation EMEA/H/C/3870 (2015)4707 of 03/07/2015
21/12/2016 Centralised - Variation EMEA/H/C/3870/IAIN/06