EMA
- Status: approved
XBB.1.5-adapted vaccinated (xbb-1-5-adapted-vaccinated) regulatory status in European Union.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA has authorised it.
Pfizer is the originator. The local marketing authorisation holder may differ — check the official source linked above.