EMEA-003542-PIP01-23 - paediatric investigation plan

propylene glycol / urea

Key facts

• Active Substance:
  propylene glycol / urea
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0127/2024
• PIP number:
  EMEA-003542-PIP01-23
• Pharmaceutical form(s):
  Cutaneous emulsion
• Condition(s) / indication(s):
  Treatment of dry skin
• Route(s) of administration:
  Cutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/04/2024

Decision

P/0127/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for propylene glycol / urea (EMEA-003542-PIP01-23)