EMA — authorised 26 May 2010
- Marketing authorisation holder: Amgen Europe B.V.
- Status: approved
🇪🇺 Prolia in European Union
EMA authorised Prolia on 26 May 2010
Marketing authorisation
Prolia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Prolia approved in European Union?
Yes. EMA authorised it on 26 May 2010.
Who is the marketing authorisation holder for Prolia in European Union?
Amgen Europe B.V. holds the EU marketing authorisation.