EMEA-000827-PIP03-11 - paediatric investigation plan

aztreonam

Key facts

• Invented name:
  • Cayston
  • Cayston
• Active substance:
  aztreonam
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0026/2013
• PIP number:
  EMEA-000827-PIP03-11
• Pharmaceutical form(s):
  Powder and solvent for nebuliser solution
• Condition(s) / indication(s):
  Treatment of Gram-negative endobronchial infection in bronchiectasis patients
• Route(s) of administration:
  Inhalation use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  26/02/2013
• Compliance check done:
  Nej

Decision

P/0026/2013: EMA decision of 26 February 2013 on the granting of a product specific waiver for aztreonam (Cayston), (EMEA-000827-PIP03-11)

Adopted Reference Number: EMA/75621/2013