Evrysdi
risdiplam
Table of contents
Overview
Evrysdi is a medicine used to treat patients from 2 months old with 5q spinal muscular atrophy (SMA), a genetic disease that causes weakness and wasting of the muscles including the lung muscles. It is intended for patients with SMA type 1, type 2 or type 3, or those who have up to 4 copies of a gene known as SMN2.
SMA is rare, and Evrysdi was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 26 February 2019.
Evrysdi contains the active substance risdiplam.
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Evrysdi : EPAR - Medicine overview (PDF/121.02 KB)
First published: 04/05/2021 -
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Evrysdi : EPAR - Risk-management-plan summary (PDF/210.31 KB)
First published: 04/05/2021
Authorisation details
Product details | |
---|---|
Name |
Evrysdi
|
Agency product number |
EMEA/H/C/005145
|
Active substance |
Risdiplam
|
International non-proprietary name (INN) or common name |
risdiplam
|
Therapeutic area (MeSH) |
Muscular Atrophy, Spinal
|
Anatomical therapeutic chemical (ATC) code |
M09AX10
|
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 |
Roche Registration GmbH
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
26/03/2021
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
01/02/2023 Evrysdi - EMEA/H/C/005145 - N/0012
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 drugs for disorders of the musculo-skeletal system
Therapeutic indication
Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.