EMEA-000525-PIP01-08-M08 - paediatric investigation plan

Amikacin sulfate

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: [e-mail]; Telephone: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022

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)

AdoptedReference Number: EMA/145474/2022