EMA — authorised 10 June 2008
- Status: approved
EMA authorised Tykerb on 10 June 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 10 June 2008.
Novartis is the originator. The local marketing authorisation holder may differ — check the official source linked above.