EMEA-001298-PIP01-12 - paediatric investigation plan

azithromycin

Key facts

• Active substance:
  azithromycin
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0037/2013
• PIP number:
  EMEA-001298-PIP01-12
• Pharmaceutical form(s):
  Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Prevention of bronchopulmonary dysplasia
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/02/2013
• Compliance check done:
  No

Decision

P/0037/2013: EMA decision of 27 February 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for azithromycin (EMEA-001298-PIP01-12)

Adopted Reference Number: EMA/75623/2013