EMA — authorised 1 June 2018
- Application: EMEA/H/C/004355
- Marketing authorisation holder: AVI Biopharma International Ltd
- Local brand name: Exondys
- Indication: Treatment of Duchenne muscular dystrophy.
- Pathway: orphan
- Status: rejected
🇪🇺 Exondys 51 in European Union
EMA authorised Exondys 51 on 1 June 2018
Marketing authorisation
Exondys 51 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Exondys 51 approved in European Union?
Yes. EMA authorised it on 1 June 2018.
Who is the marketing authorisation holder for Exondys 51 in European Union?
AVI Biopharma International Ltd holds the EU marketing authorisation.