EMEA-001492-PIP01-13-M01 - paediatric investigation plan

trifarotene

Key facts

• Active substance:
  trifarotene
• Therapeutic area:
  Dermatology
• Decision number:
  P/0099/2017
• PIP number:
  EMEA-001492-PIP01-13-M01
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of acne
• Route(s) of administration:
  Cutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/04/2017
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001492-PIP01-13-M01
• Compliance opinion date:
  29/06/2018
• Compliance outcome:
  Positive

Decision

P/0099/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for trifarotene (EMEA-001492-PIP01-13-M01)

Adopted Reference Number: EMA/202411/2017