EMEA-003488-PIP01-23 - paediatric investigation plan

lotilaner

Key facts

• Active substance:
  lotilaner
• Therapeutic area:
  Eye disorders
• Decision number:
  P/0535/2023
• PIP number:
  EMEA-003488-PIP01-23
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of Demodex blepharitis
• Route(s) of administration:
  Ocular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/12/2023
• Compliance check done:
  Nej

Decision

P/0535/2023: EMA decision of 29 December 2023 on the granting of a product specific waiver for lotilaner (EMEA-003488-PIP01-23)

Reference Number: EMA/562497/2023