EMEA-000176-PIP01-07-M05 - paediatric investigation plan

Colistimethate sodium

Key facts

• Invented name:
  • Colobreathe
  • Colobreathe
• Active substance:
  Colistimethate sodium
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0173/2017
• PIP number:
  EMEA-000176-PIP01-07-M05
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
• Route(s) of administration:
  Inhalation use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/07/2017
• Compliance check done:
  Nej

Decision

P/0173/2017: EMA decision of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for colistimethate sodium (Colobreathe), (EMEA-000176-PIP01-07-M05)

Adopted Reference Number: EMA/357972/2017