Arikayce liposomal



This medicine is authorised for use in the European Union.


Arikayce liposomal is an antibiotic for treating adults with a lung infection caused by Mycobacterium avium complex (MAC), a group of bacteria commonly found in the environment, such as in soil and water. It is used in patients with limited treatment options who do not have cystic fibrosis.

Lung infection caused by MAC is rare, and Arikayce liposomal was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 April 2014.

Arikayce liposomal contains the active substance amikacin.

This EPAR was last updated on 04/08/2023

Authorisation details

Product details
Arikayce liposomal
Agency product number
Active substance
Amikacin sulfate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Respiratory Tract Infections
Anatomical therapeutic chemical (ATC) code

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Insmed Netherlands B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Stadsplateau 7
3521 AZ Utrecht

Product information

29/06/2023 Arikayce liposomal - EMEA/H/C/005264 - PSUSA/00010882/202209

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic 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.

Assessment history

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