EMEA-002053-PIP01-16 - paediatric investigation plan

Polihexanide

Key facts

• Active substance:
  Polihexanide
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0134/2017
• PIP number:
  EMEA-002053-PIP01-16
• Pharmaceutical form(s):
  • Eye drops, solution
  • Solution
• Condition(s) / indication(s):
  Treatment of Acanthamoeba keratitis
• Route(s) of administration:
  Ocular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/06/2017
• Compliance check done:
  No

Decision

P/0134/2017: EMA decision of 7 June 2017 on the refusal of a paediatric investigation plan and on the granting of a waiver for polihexanide (PHMB) (EMEA-002053-PIP01-16)

Adopted Reference Number: EMA/307704/2017