EMA — authorised 12 December 2014
- Marketing authorisation holder: Clinuvel UK Limited
- Status: approved
EMA authorised Scenesse on 12 December 2014
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 12 December 2014; EMA authorised it on 22 December 2014.
Clinuvel UK Limited holds the EU marketing authorisation.