This medicine is authorised for use in the European Union.


Evrysdi is a medicine used to treat patients 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. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3192145.

Evrysdi contains the active substance risdiplam. 

This EPAR was last updated on 22/09/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Muscular Atrophy, Spinal
Anatomical therapeutic chemical (ATC) code
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.

Publication details
Marketing-authorisation holder
Roche Registration GmbH 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen

Product information

16/08/2023 Evrysdi - EMEA/H/C/005145 - II/0005/G

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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 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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