MHRA-100645-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • AMIKACIN SULFATE
Invented Name
  • Arikayce
  • Arikayce
  • Arikayce liposomal
PIP Number MHRA-100645-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Nebuliser dispersion
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
  • Treatment of Pseudomonas aeruginosa lung infection/colonisation in cystic fibrosis patients
  • Treatment of non-tuberculous mycobacterial lung infection
Route(s) of administration
Route(s) of administration:
  • Inhalation use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AMIKACIN SULFATE.pdf
Published Date 30/06/2023