🇪🇺 Amikacin Injection in European Union

EMA authorised Amikacin Injection on 27 October 2020

Marketing authorisation

EMA — authorised 27 October 2020

  • Application: EMEA/H/C/005264
  • Marketing authorisation holder: Insmed Netherlands B.V.
  • Local brand name: Arikayce liposomal
  • Indication: Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.
  • Pathway: orphan
  • Status: approved

Read official source →

Amikacin Injection in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in European Union

Frequently asked questions

Is Amikacin Injection approved in European Union?

Yes. EMA authorised it on 27 October 2020.

Who is the marketing authorisation holder for Amikacin Injection in European Union?

Insmed Netherlands B.V. holds the EU marketing authorisation.