EMA — authorised 23 August 2018
- Marketing authorisation holder: ULTRAGENYX PHARM INC
- Status: approved
EMA authorised Mepsevii on 23 August 2018
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 23 August 2018.
ULTRAGENYX PHARM INC holds the EU marketing authorisation.