Onpattro

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patisiran

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

Overview

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

Onpattro 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 amyloidosis is rare, and Onpattro was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 April 2011.

Onpattro contains the active substance patisiran.

This EPAR was last updated on 22/08/2019

Authorisation details

Product details
Name
Onpattro
Agency product number
EMEA/H/C/004699
Active substance
patisiran sodium
International non-proprietary name (INN) or common name
patisiran
Therapeutic area (MeSH)
Amyloidosis, Familial
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
Alnylam Netherlands B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
27/08/2018
Contact address
Strawinskylaan 3051 1077 ZX
Amsterdam
Netherlands

Product information

19/07/2019 Onpattro - EMEA/H/C/004699 - IB/0006

Contents

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Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Assessment history

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