EMEA-001514-PIP01-13-M01 - paediatric investigation plan

octenidine dihydrochloride

Key facts

• Invented name:
  Laryngomedin Octenidin Antisept and associated names
• Active substance:
  octenidine dihydrochloride
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/0269/2019
• PIP number:
  EMEA-001514-PIP01-13-M01
• Pharmaceutical form(s):
  Lozenge
• Condition(s) / indication(s):
  Treatment of upper respiratory tract infections
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/08/2019
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001514-PIP01-13-M01
• Compliance opinion date:
  11/12/2019
• Compliance outcome:
  Positive

Decision

P/0269/2019: EMA decision of 14 August 2019 on the acceptance of a modification of an agreed paediatric investigation plan for octenidine (dihydrochloride) (Laryngomedin Octenidin Antisept and associated names), (EMEA-001514-PIP01-13-M01)

Adopted Reference Number: EMA/392672/2019