EMEA-002535-PIP04-21 - paediatric investigation plan

Ibrexafungerp citrate

Key facts

• Active Substance:
  Ibrexafungerp citrate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0370/2022
• PIP number:
  EMEA-002535-PIP04-21
• Pharmaceutical form(s):
  • Tablet
  • Powder for oral solution
  • Powder for solution for injection or infusion
• Condition(s) / indication(s):
  Treatment of invasive candidiasis
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Contact for public enquiries:

  SCYNEXIS, Inc.

  Tel.: [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/09/2022

Decision

P/0370/2022 : of 9 September 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for ibrexafungerp citrate (EMEA-002535-PIP04-21)

AdoptedReference Number: EMA/697763/2022