Tegsedi

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inotersen

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Tegsedi and why it is authorised in the EU

Tegsedi is a medicine used to treat nerve damage caused by hereditary transthyretin amyloidosis (hATTR), a disease in which proteins called amyloids build up in tissues around the body including around the nerves.

Tegsedi is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk unaided, and stage 2, when the patient can still walk but needs help).

hATTR is rare, and Tegsedi was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 26 March 2014.

This EPAR was last updated on 06/08/2018

Authorisation details

Product details
Name
Tegsedi
Agency product number
EMEA/H/C/004782
Active substance
inotersen sodium
International non-proprietary name (INN) or common name
inotersen
Therapeutic area (MeSH)
Amyloidosis
Anatomical therapeutic chemical (ATC) code
N07
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Ionis USA Ltd
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
06/07/2018
Contact address
Tower 42 Level 30
International Finance Centre
25 Old Broad Street
London EC2N 1HQ
United Kingdom

Product information

06/07/2018 Tegsedi - EMEA/H/C/004782 - -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

OTHER NERVOUS SYSTEM DRUGS

Therapeutic indication

Treatment of stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

Assessment history

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