Onpattro
patisiran
Table of contents
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.
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List item
Onpattro : EPAR - Medicine overview (PDF/99.12 KB)
First published: 30/10/2018
EMA/521473/2018 -
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List item
Onpattro : EPAR - Risk-management-plan summary (PDF/97.12 KB)
First published: 30/10/2018
Authorisation details
Product details | |
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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 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 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 | |
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Marketing-authorisation holder |
Alnylam Netherlands B.V.
|
Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
27/08/2018
|
Contact address |
Product information
19/07/2019 Onpattro - EMEA/H/C/004699 - IB/0006
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
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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.