Tegsedi

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inotersen

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

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.

This EPAR was last updated on 27/09/2019

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 assessmentAccelerated 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.

Additional monitoringAdditional 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.

OrphanOrphan

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
Akcea Therapeutics Ireland Limited
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
05/07/2018
Contact address

Regus House, Harcourt Centre,
Harcourt Road
Dublin 2
Ireland

Product information

19/09/2019 Tegsedi - EMEA/H/C/004782 - PSUSA/00010697/201901

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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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