EMA — authorised 15 September 2011
- Marketing authorisation holder: Orion Corporation
- Status: approved
EMA authorised Precedex on 15 September 2011
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 15 September 2011.
Orion Corporation holds the EU marketing authorisation.