EMA/PE/0000233717 - paediatric investigation plan

benzoyl peroxide (hydrous)

Key facts

• Active substance:
  benzoyl peroxide (hydrous)
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  EMA/PE/0000233717
• PIP number:
  EMA/PE/0000233717
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of rosacea
• Route(s) of administration:
  Topical use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/03/2025
• Compliance check done:
  Nem

Decision

EMA/PE/0000233717: EMA decision of 21 March 2025 on the granting of a product specific waiver for benzoyl peroxide (hydrous)

Adopted Reference Number: EMADOC-1700519818-1975046