Tegsedi
inotersen
Table of contents
Overview
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.
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List item
Tegsedi : EPAR - Summary for the public (PDF/78.21 KB)
First published: 06/08/2018
Last updated: 06/08/2018
EMA/381704/2018 -
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List item
Tegsedi : EPAR - Risk-management-plan summary (PDF/125.65 KB)
First published: 06/08/2018
Last updated: 18/03/2022
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
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
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 | |
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Marketing-authorisation holder |
Akcea Therapeutics Ireland Limited
|
Revision |
14
|
Date of issue of marketing authorisation valid throughout the European Union |
06/07/2018
|
Contact address |
St. James House |
Product information
19/04/2023 Tegsedi - EMEA/H/C/004782 - PSUSA/00010697/202207
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Other nervous system drugs
Therapeutic indication
Treatment of stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).