EMA — authorised 28 August 2008
- Status: approved
EMA authorised Intelence on 28 August 2008
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 28 August 2008.
Janssen R And D is the originator. The local marketing authorisation holder may differ — check the official source linked above.