Pharmaceuticals - Union Register

  

Union 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 7/07/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 7/07/2025
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 Germany GmbH
Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
7/07/2015 Centralised - Authorisation EMEA/H/C/3870 (2015)4707 of 3/07/2015
21/12/2016 Centralised - Variation EMEA/H/C/3870/IAIN/6
Updated with Decision(2017)8311 of 01/12/2017
6/07/2017 Centralised - Variation EMEA/H/C/3870/II/8
Updated with Decision(2017)8311 of 01/12/2017
5/12/2017 Centralised - Yearly update (2017)8311 of 1/12/2017
27/02/2019 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/3870/T/13 (2019)1668 of 25/02/2019
29/03/2019 Centralised - Variation EMEA/H/C/3870/IAin/14/G