EMA
- Application: EMEA/H/C/005966
- Local brand name: Leqembi
- Status: approved
Leqembi (LECANEMAB) 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.
Eisai is the originator. The local marketing authorisation holder may differ — check the official source linked above.