EMEA-002392-PIP01-18-M02 - paediatric investigation plan

oteseconazole

Key facts

• Active substance:
  oteseconazole
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0460/2021
• PIP number:
  EMEA-002392-PIP01-18-M02
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  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:
  29/10/2021
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-002392-PIP01-18-M02
• Compliance opinion date:
  16/12/2022
• Compliance outcome:
  Positive

Decision

P/0460/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for oteseconazole (EMEA-002392-PIP01-18-M02)

Reference Number: EMA/532345/2021