EMEA-000525-PIP01-08-M06

Key facts

Active substance
Amikacin (sulfate)
Therapeutic area
  • Infectious diseases
  • Pneumology-allergology
Decision number
P/0346/2018
PIP number
EMEA-000525-PIP01-08-M06
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 Limited

Tel. +1 9089474303
E-mail: Diana.Fiorenza@insmed.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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