EMEA-003280-PIP01-22 - paediatric investigation plan

Fosmanogepix

Key facts

• Active substance:
  Fosmanogepix
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0228/2023
• PIP number:
  EMEA-003280-PIP01-22
• Pharmaceutical form(s):
  • Solution for infusion
  • Age appropriate dosage form for parenteral use
  • Tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of invasive fungal infections
• Route(s) of administration:
  • Intravenous use
  • Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/06/2023
• Compliance check done:
  No

Decision

P/0228/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for fosmanogepix, (EMEA-003280-PIP01-22)

Reference Number: EMA/239204/2023