EMA — authorised 7 February 2019
- Marketing authorisation holder: ALEXION EUROPE SAS
- Status: approved
🇪🇺 Ultomiris in European Union
EMA authorised Ultomiris on 7 February 2019
Marketing authorisation
Ultomiris in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in European Union
Frequently asked questions
Is Ultomiris approved in European Union?
Yes. EMA authorised it on 7 February 2019.
Who is the marketing authorisation holder for Ultomiris in European Union?
ALEXION EUROPE SAS holds the EU marketing authorisation.