EMA — authorised 29 June 2016
- Marketing authorisation holder: AOP Orphan Pharmaceuticals AG
- Status: approved
EMA authorised Onoact on 29 June 2016
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 29 June 2016.
AOP Orphan Pharmaceuticals AG holds the EU marketing authorisation.