EMA — authorised 23 February 2018
- Marketing authorisation holder: Roche Registration Limited
- Status: approved
🇪🇺 Hemlibra in European Union
EMA authorised Hemlibra on 23 February 2018
Marketing authorisation
Hemlibra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in European Union
Frequently asked questions
Is Hemlibra approved in European Union?
Yes. EMA authorised it on 23 February 2018.
Who is the marketing authorisation holder for Hemlibra in European Union?
Roche Registration Limited holds the EU marketing authorisation.