Key facts

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
Decision date

Decision

P/0107/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for amikacin (sulfate) (Arikayce liposomal), (EMEA-000525-PIP01-08-M08)

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