EMEA-001627-PIP01-14-M02 - paediatric investigation plan

Efinaconazole

Key facts

• Active Substance:
  Efinaconazole
• Therapeutic area:
  • Dermatology
  • Infectious diseases
• Decision number:
  P/0195/2022
• PIP number:
  EMEA-001627-PIP01-14-M02
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Treatment of onychomycosis
• Route(s) of administration:
  Cutaneous use
• Contact for public enquiries:

  Almirall, S.A.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/06/2022

Decision

P/0195/2022: EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for efinaconazole (EMEA- 001627-PIP01-14-M02)

AdoptedReference Number: EMA/352509/2022