EMA
- Application: EMEA/H/C/005264
- Local brand name: Arikayce liposomal
- Status: approved
Arikayce Kit (AMIKACIN) 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.
Bristol-Myers Squibb is the originator. The local marketing authorisation holder may differ — check the official source linked above.