Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1831429
Name of medicinal product: ARIKAYCE LIPOSOMAL
Active substances:
Amikacin
Estonian, English, Latin
ATC code: J01GB06
Dosage form: nebuliser dispersion
Route of administration: inhalation use
Strengh: 590mg
Amount in package: 28TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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 (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Insmed Netherlands B.V. 
Marketing authorization number: EU/1/20/1469 
Marketing authorization issued on: October 27, 2020 
Marketing authorization expires on: October 28, 2025 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada
Entry/Changing date: November 20, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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