MHRA-100150-PIP01-21

Key Facts

Active Substance
Active Substance:
  • AZITHROMYCIN
Invented Name
Not yet available
PIP Number MHRA-100150-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Age appropriate dosage form for parenteral use.
Therapeutic area
  • Pneumology - Allergology
  • Neonatology - Paediatric Intensive Care
Conditions / Indications
Conditions / Indications:
  • Prevention of bronchopulmonary dysplasia (BPD)
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AZITHROMYCIN.pdf
Published Date 17/05/2022