Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/10/841   
Active ingredient: Tasimelteon
Indication: Treatment of non-24-hour sleep-wake disorders in blind people with no light perception
Sponsor: Vanda Pharmaceuticals Limited
25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Hetlioz on 7/07/2015 with the number EU/1/15/1008

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
1/03/2011 Orphan designation EMA/OD/102/10 (2011)1307 of 23/02/2011
24/11/2014 Change of name and/or address of sponsor
20/12/2016 Change of name and/or address of sponsor