EMEA-003021-PIP01-21 - paediatric investigation plan

Azithromycin

Key facts

• Active Substance:
  Azithromycin
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0381/2021
• PIP number:
  EMEA-003021-PIP01-21
• Pharmaceutical form(s):
  Age-appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Prevention of bronchopulmonary dysplasia
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Aspire Pharma Limited

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/09/2021

Decision

P/0381/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a waiver for azithromycin (EMEA-003021-PIP01-21)

AdoptedReference Number: EMA/464763/2021