EMEA-000989-PIP01-10-M02 - paediatric investigation plan

chlorhexidine gluconate

isopropyl alcohol

Key facts

• Active substance:
  • chlorhexidine gluconate
  • isopropyl alcohol
• Therapeutic area:
  Other
• Decision number:
  P/0231/2017
• PIP number:
  EMEA-000989-PIP01-10-M02
• Pharmaceutical form(s):
  Solution
• Condition(s) / indication(s):
  Prevention of infection prior to invasive procedures
• Route(s) of administration:
  Cutaneous use
• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  11/08/2017
• Compliance check done:
  No

Decision

P/0231/2017: EMA decision of 11 August 2017 on the refusal of a modification of an agreed paediatric investigation plan for chlorhexidine gluconate / isopropyl alcohol (EMEA-000989-PIP01-10-M02)

Adopted Reference Number: EMA/460041/2017