EMEA-000347-PIP02-16-M05 - paediatric investigation plan

bilastine

Key facts

• Invented name:
  Bilaxten and associated names
• Active substance:
  bilastine
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0209/2023
• PIP number:
  EMEA-000347-PIP02-16-M05
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of allergic conjunctivitis
• Route(s) of administration:
  Ocular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000347-PIP02-16-M05
• Compliance opinion date:
  22/03/2024
• Compliance outcome:
  Positive

Decision

P/0209/2023: EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten and associated names), (EMEA-000347-PIP02-16-M05)

Reference Number: EMA/236606/2023