EMA/PE/0000225106 - paediatric investigation plan

Ibrexafungerp

Key facts

• Active substance:
  Ibrexafungerp
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000225106
• PIP number:
  EMA/PE/0000225106
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Prevention of recurrent vulvovaginal candidiasis
  • Treatment of vulvovaginal candidiasis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

EMA/PE/0000225106: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ibrexafungerp (EMA/PE/0000225106)

Adopted Reference Number: EMADOC-1700519818-1723829