EMA — authorised 24 June 2016
- Marketing authorisation holder: Bial
- Status: approved
EMA authorised Ongentys on 24 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 24 June 2016.
Bial holds the EU marketing authorisation.