EMEA-000347-PIP02-16-M04 - paediatric investigation plan

Bilastine

Key facts

• Invented name:
  Bilaxten and associated names
• Active Substance:
  Bilastine
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0506/2022
• PIP number:
  EMEA-000347-PIP02-16-M04
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of allergic conjunctivitis
• Route(s) of administration:
  Ocular use
• Contact for public enquiries:

  FAES FARMA, S.A.

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/12/2022

Decision

P/0506/2022: EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten), (EMEA-000347-PIP02-16-M04)

AdoptedReference Number: EMA/898469/2022