MHRA-100479-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • POSACONAZOLE
Invented Name
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
PIP Number MHRA-100479-PIP01-22-M02 (update)
Pharmaceutical form(s)
  • Gastro-resistant tablet
  • Concentrate for solution for infusion
  • Oral suspension
  • Gastro-resistant powder for oral suspension
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
  • Prevention of invasive fungal infections
  • Treatment of invasive fungal infections
Route(s) of administration
  • Oral use
  • intravenous
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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):POSACONAZOLE.pdf
Published Date 30/04/2024