🇪🇺 Arikayce in European Union

EMA authorised Arikayce on 24 June 2016

Marketing authorisation

EMA — authorised 24 June 2016

  • Application: EMEA/H/C/003936
  • Marketing authorisation holder: Insmed Limited
  • Local brand name: Arikayce
  • Indication: Arikayce is indicated for: treatment of Mycobacterium avium Complex (MAC) lung disease in adult patients who have persistent positive sputum cultures despite the use of medically appropriate first-line therapy Consideration should be given to official guidance on the appropriate use of antibacterial agents. Arikayce should be added to existing therapy and should not be used as monotherapy.
  • Status: withdrawn

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Arikayce in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Arikayce approved in European Union?

Yes. EMA authorised it on 24 June 2016.

Who is the marketing authorisation holder for Arikayce in European Union?

Insmed Limited holds the EU marketing authorisation.