EMEA-000468-PIP02-12-M09 - paediatric investigation plan

posaconazole

Key facts

• Invented name:
  Noxafil
• Active substance:
  posaconazole
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0376/2024
• PIP number:
  EMEA-000468-PIP02-12-M09
• Pharmaceutical form(s):
  • Oral suspension
  • Gastro-resistant tablet
  • Gastro-resistant powder for oral suspension
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Prevention of invasive fungal infections
  • Treatment of invasive fungal infections
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0376/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for posaconazole (Noxafil), (EMEA-000468-PIP02-12-M09)

Adopted Reference Number: EMA/465528/2024