Amvuttra
vutrisiran
Table of contents
Overview
Amvuttra is a medicine used to treat polyneuropathy (nerve damage) caused by hereditary transthyretin-mediated (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.
Amvuttra is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient has weakness in the legs but is able to walk unaided, and stage 2, when the patient can still walk but needs help).
hATTR amyloidosis is rare, and Amvuttra was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 25 May 2018. Further information on the orphan designation can be found here.
Amvuttra contains the active substance vutrisiran.
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Amvuttra : EPAR - Medicine Overview (PDF/119.53 KB)
First published: 12/10/2022
EMA/669739/2022 -
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Amvuttra : EPAR - Risk management plan (PDF/671.73 KB)
First published: 12/10/2022
Authorisation details
Product details | |
---|---|
Name |
Amvuttra
|
Agency product number |
EMEA/H/C/005852
|
Active substance |
vutrisiran sodium
|
International non-proprietary name (INN) or common name |
vutrisiran
|
Therapeutic area (MeSH) |
Amyloid Neuropathies, Familial
|
Anatomical therapeutic chemical (ATC) code |
N07XX18
|
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 |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
15/09/2022
|
Contact address |
Antonio Vivaldistraat 150 |
Product information
10/01/2023 Amvuttra - EMEA/H/C/005852 - IB/0002
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 hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.