EMA
- Application: EMEA/H/C/006498
- Marketing authorisation holder: Novartis Europharm Limited
- Local brand name: Itvisma
- Indication: Treatment of 5q spinal muscular atrophy (SMA)
- Pathway: orphan
- Status: approved
🇪🇺 Onasemnogene Abeparvovec-brve in European Union
Onasemnogene Abeparvovec-brve (Onasemnogene Abeparvovec-brve) regulatory status in European Union.
Marketing authorisation
Onasemnogene Abeparvovec-brve 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 Onasemnogene Abeparvovec-brve approved in European Union?
Yes. EMA has authorised it.
Who is the marketing authorisation holder for Onasemnogene Abeparvovec-brve in European Union?
Novartis Europharm Limited holds the EU marketing authorisation.