EMEA-000525-PIP01-08-M07

Adopted

First published: 12/01/2023
EMA/439771/2021

Active substance	Amikacin sulfate
Therapeutic area	Pneumology-allergology
Decision number	P/0358/2021
PIP number	EMEA-000525-PIP01-08-M07
Pharmaceutical form(s)	Nebuliser suspension
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 Tel: +1 908 977 9900
Decision type	PM: decision on the application for modification of an agreed PIP