EMEA-001884-PIP03-18 - paediatric investigation plan

Hydrogen Peroxide

Key facts

• Active Substance:
  Hydrogen Peroxide
• Therapeutic area:
  Dermatology
• Decision number:
  P/0268/2019
• PIP number:
  EMEA-001884-PIP03-18
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Treatment of common warts (verrucae vulgaris)
• Route(s) of administration:
  Cutaneous use
• Contact for public enquiries:

  Aclaris Therapeutics, Inc.

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

• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  25/07/2019

Decision

P/0268/2019: EMA decision of 25 July 2019 on the refusal of a paediatric investigation plan and on the granting of a waiver for hydrogen peroxide (45%) (EMEA-001884-PIP03-18)

AdoptedReference Number: EMA/408892/2019