EMA — authorised 26 March 2021
- Marketing authorisation holder: Roche Registration GmbH
- Status: approved
🇪🇺 Evrysdi in European Union
EMA authorised Evrysdi on 26 March 2021
Marketing authorisations
EMA — authorised 26 March 2021
- Application: EMEA/H/C/005145
- Marketing authorisation holder: Roche Registration GmbH
- Local brand name: Evrysdi
- 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.
- Pathway: accelerated assessment, PRIME
- Status: approved
Evrysdi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in European Union
Frequently asked questions
Is Evrysdi approved in European Union?
Yes. EMA authorised it on 26 March 2021; EMA authorised it on 26 March 2021.
Who is the marketing authorisation holder for Evrysdi in European Union?
Roche Registration GmbH holds the EU marketing authorisation.