Evrysdi

RSS

risdiplam

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

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.

This EPAR was last updated on 19/01/2022

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 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.

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
Roche Registration GmbH 
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
26/03/2021
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

18/11/2021 Evrysdi - EMEA/H/C/005145 - II/0003

Product information documents contain:

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.

Assessment history

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