EMA — authorised 20 May 2016
- Marketing authorisation holder: Janssen-Cilag International N.V.
- Status: approved
🇪🇺 Darzalex in European Union
EMA authorised Darzalex on 20 May 2016
Marketing authorisation
Darzalex 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 Darzalex approved in European Union?
Yes. EMA authorised it on 20 May 2016.
Who is the marketing authorisation holder for Darzalex in European Union?
Janssen-Cilag International N.V. holds the EU marketing authorisation.