EMA — authorised 27 May 2015
- Marketing authorisation holder: Helsinn Birex Pharmaceuticals Ltd
- Status: approved
EMA authorised Akynzeo on 27 May 2015
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 27 May 2015.
Helsinn Birex Pharmaceuticals Ltd holds the EU marketing authorisation.