EMEA-003263-PIP01-22 - paediatric investigation plan

clindamycin phosphate

benzoyl peroxide

adapalene

Key facts

• Active substance:
  • clindamycin phosphate
  • benzoyl peroxide
  • adapalene
• Therapeutic area:
  Dermatology
• Decision number:
  P/0269/2023
• PIP number:
  EMEA-003263-PIP01-22
• Pharmaceutical form(s):
  Gel
• Condition(s) / indication(s):
  Treatment of acne vulgaris
• 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:
  14/07/2023
• Compliance check done:
  Ne

Decision

P/0269/2023 : EMA decision of 14 July 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for clindamycin phosphate / benzoyl peroxide (hydrous) / adapalene (micronized) (EMEA-003263-PIP01-22)

Reference Number: EMA/285269/2023