EMEA-000184-PIP02-14 - paediatric investigation plan

tobramycin

Key facts

• Invented name:
  Tobi
• Active substance:
  tobramycin
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0184/2014
• PIP number:
  EMEA-000184-PIP02-14
• Pharmaceutical form(s):
  Nebuliser solution
• Condition(s) / indication(s):
  Treatment of Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
• Route(s) of administration:
  Inhalation use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/08/2014
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000184-PIP02-14
• Compliance opinion date:
  29/04/2016
• Compliance outcome:
  Positive

Decision

P/0184/2014: EMA decision of 6 August 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for tobramycin (TOBI), (EMEA-000184-PIP02-14)

Adopted Reference Number: EMA/414809/2014