EMEA-001384-PIP01-12 - paediatric investigation plan

octenidine dihydrochloride

Key facts

• Active substance:
  octenidine dihydrochloride
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0360/2016
• PIP number:
  EMEA-001384-PIP01-12
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Skin disinfection
• Route(s) of administration:
  Cutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/12/2016
• Compliance check done:
  Ei

Decision

P/0360/2016: EMA decision of 21 December 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for octenidine (dihydrochloride) (EMEA-001384-PIP01-12)

Adopted Reference Number: EMA/791551/2016