EMA
- Status: approved
BNT162b2 BA.4/5 bivalent (bnt162b2-ba-4-5-bivalent) 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.