EMEA-002011-PIP01-16 - paediatric investigation plan

Chlorhexidine gluconate

isopropyl alcohol

Key facts

• Active Substance:
  • Chlorhexidine gluconate
  • isopropyl alcohol
• Therapeutic area:
  Dermatology
• Decision number:
  P/0348/2016
• PIP number:
  EMEA-002011-PIP01-16
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Prevention of infections prior to invasive procedures
• Route(s) of administration:
  Cutaneous use
• Contact for public enquiries:

  GAMA Healthcare Ltd

  United Kingdom; E-mail: [e-mail]; Tel.: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/12/2016

Decision

P/0348/2016: EMA decision of 2 December 2016 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for chlorhexidine gluconate / isopropyl alcohol (EMEA-00201...

AdoptedReference Number: EMA/742003/2016