EMEA-000525-PIP01-08-M08

Adopted

First published: 17/04/2023
EMA/145474/2022

Invented name	Arikayce liposomal
Active substance	Amikacin sulfate
Therapeutic area	Pneumology-allergology
Decision number	P/0107/2022
PIP number	EMEA-000525-PIP01-08-M08
Pharmaceutical form(s)	Nebuliser dispersion
Condition(s) / indication(s)	Treatment of nontuberculous mycobacterial lung infection Treatment of Pseudomonas aeruginosa lung infection/colonisation in cystic fibrosis patients
Route(s) of administration	Inhalation use
Contact for public enquiries	Insmed Netherlands B.V. E-mail: medicalinformation@insmed.com Telephone: +1 9089474303
Decision type	PM: decision on the application for modification of an agreed PIP