Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: Tegsedi   
Auth. number : EU/1/18/1296
Active substance : inotersen
Orphan market exclusivity for "Treatment of ATTR amyloidosis" (based on designation EU/3/14/1250) started on 10/07/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 10/07/2028
ATC: Pending
Indication: Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).
Marketing Authorisation Holder: Akcea Therapeutics Ireland Ltd
Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

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
10/07/2018 Centralised - Authorisation EMEA/H/C/4782 (2018)4458 of 6/07/2018
14/09/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4782/T/1 (2018)6027 of 12/09/2018
5/03/2019 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/004782/T/0003 (2019)1826 of 1/03/2019