EMEA-001563-PIP02-15-M01 - paediatric investigation plan

ciprofloxacin hydrochloride

Key facts

• Active substance:
  ciprofloxacin hydrochloride
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0253/2018
• PIP number:
  EMEA-001563-PIP02-15-M01
• Pharmaceutical form(s):
  Nebuliser solution
• Condition(s) / indication(s):
  Treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa
• Route(s) of administration:
  Inhalation use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/08/2018
• Compliance check done:
  Nej

Decision

P/0253/2018: EMA decision of 15 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ciprofloxacin (hydrochloride) (EMEA-001563-PIP02-15-M01)

Adopted Reference Number: EMA/472033/2018