MHRA-100612-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Fosmanogepix
Invented Name
Not yet available
PIP Number MHRA-100612-PIP01-22
Pharmaceutical form(s)
  • Solution for infusion
  • Age appropriate parenteral formulation
  • Tablet
  • Age appropriate oral formulation
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of invasive fungal infections
Route(s) of administration
  • Intravenous use
  • ORAL 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):Fosmanogepix.pdf
Published Date 24/08/2023