Arikayce liposomal

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amikacin

Authorised
This medicine is authorised for use in the European Union.

Overview

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 18/11/2020

Authorisation details

Product details
Name
Arikayce liposomal
Agency product number
EMEA/H/C/005264
Active substance
Amikacin sulfate
International non-proprietary name (INN) or common name
amikacin
Therapeutic area (MeSH)
Respiratory Tract Infections
Anatomical therapeutic chemical (ATC) code
J01GB06
OrphanOrphan

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
27/10/2020
Contact address

Stadsplateau 7
3521 AZ Utrecht
Netherlands

Product information

27/10/2020 Arikayce liposomal - EMEA/H/C/005264 -

Contents

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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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