EMEA-003330-PIP01-22 - paediatric investigation plan

clascoterone

Key facts

• Active Substance:
  clascoterone
• Therapeutic area:
  Dermatology
• Decision number:
  P/0076/2023
• PIP number:
  EMEA-003330-PIP01-22
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of acne vulgaris
• Route(s) of administration:
  Topical use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/03/2023
• Compliance procedure number:
  EMEA-C-003330-PIP01-22
• Compliance opinion date:
  23/06/2023
• Compliance outcome:
  Positive

Decision

P/0076/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for clascoterone (EMEA-003330-PIP01-22)

Reference Number: EMA/85651/2023