Pharmaceuticals - Community Register


Community 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: IONIS USA Limited
Tower 42, Level 30, International Finance Centre, 25 Old Broad Street, EC2N 1HQ London, United Kingdom

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
10/07/2018 Centralised - Authorisation EMEA/H/C/4782 (2018)4458 of 6/07/2018