EMEA-003604-PIP01-24 - paediatric investigation plan

luliconazole

Key facts

• Active substance:
  luliconazole
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0006/2025
• PIP number:
  EMEA-003604-PIP01-24
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Treatment of onychomycosis
• Route(s) of administration:
  Cutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/01/2025
• Compliance check done:
  No

Decision

P/0006/2025 : EMA decision of 27 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for luliconazole (EMEA-003604-PIP01-24)

Adopted Reference Number: EMA/25301/2025