EMA — authorised 31 March 2016
- Marketing authorisation holder: Bioprojet Pharma
- Status: approved
🇪🇺 Wakix in European Union
EMA authorised Wakix on 31 March 2016
Marketing authorisations
EMA — authorised 31 March 2016
- Application: EMEA/H/C/002616
- Marketing authorisation holder: Bioprojet Pharma
- Local brand name: Wakix
- Indication: Wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.1).
- Pathway: orphan
- Status: approved
Wakix 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 Wakix approved in European Union?
Yes. EMA authorised it on 31 March 2016; EMA authorised it on 31 March 2016.
Who is the marketing authorisation holder for Wakix in European Union?
Bioprojet Pharma holds the EU marketing authorisation.