EMEA-001627-PIP01-14-M03 - paediatric investigation plan

Efinaconazole

Key facts

• Active substance:
  Efinaconazole
• Therapeutic area:
  • Dermatology
  • Infectious diseases
• Decision number:
  P/0203/2023
• PIP number:
  EMEA-001627-PIP01-14-M03
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Treatment of onychomycosis
• Route(s) of administration:
  Cutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/06/2023
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001627-PIP01-14-M03
• Compliance opinion date:
  26/07/2024
• Compliance outcome:
  Positive

Decision

P/0203/2023 : EMA decision of 13 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for efinaconazole (EMEA- 001627-PIP01-14-M03)

Reference Number: EMA/241957/2023