EMA — authorised 14 January 2019
- Marketing authorisation holder: JANSSEN-CILAG INTERNATIONAL N.V.
- Status: approved
EMA authorised Erleada on 14 January 2019
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 14 January 2019.
JANSSEN-CILAG INTERNATIONAL N.V. holds the EU marketing authorisation.