Arikayce liposomal
amikacin
Table of contents
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.
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Arikayce liposomal : EPAR - Medicine overview (PDF/123.44 KB)
First published: 18/11/2020
EMA/446084/2020 -
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Arikayce liposomal : EPAR - Risk-management-plan summary (PDF/382.45 KB)
First published: 18/11/2020
Authorisation details
Product details | |
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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
|
Orphan |
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 | |
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Marketing-authorisation holder |
Insmed Netherlands B.V.
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
27/10/2020
|
Contact address |
Stadsplateau 7 |
Product information
29/06/2023 Arikayce liposomal - EMEA/H/C/005264 - PSUSA/00010882/202209
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.