EMEA-000827-PIP01-09-M05 - paediatric investigation plan

aztreonam

Key facts

• Invented name:
  • Cayston
  • Cayston
• Active substance:
  aztreonam
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0494/2020
• PIP number:
  EMEA-000827-PIP01-09-M05
• Pharmaceutical form(s):
  Powder and solvent for 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/12/2020
• Compliance check done:
  Nie

Decision

P/0494/2020 : EMA decision of 21 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for aztreonam (Cayston) (EMEA-000827-PIP01-09-M05)

Adopted Reference Number: EMA/631870/2020