EMEA-000414-PIP02-11 - paediatric investigation plan

Ethanol

Key facts

• Active Substance:
  Ethanol
• Therapeutic area:
  Dermatology
• Decision number:
  P/0142/2012
• PIP number:
  EMEA-000414-PIP02-11
• Pharmaceutical form(s):
  Gel for injection
• Condition(s) / indication(s):
  Treatment of congenital venous malformations
• Route(s) of administration:
  Intralesional use
• Contact for public enquiries:

  Orphagen

  [e-mail]; France; [phone]; [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  23/07/2012

Decision

P/0142/2012: EMA decision of 23 July 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for ethanol (EMEA-000414-PIP02-11)

AdoptedReference Number: EMA/394700/2012