EMEA-002558-PIP01-19 - paediatric investigation plan

brimonidine

Key facts

• Active Substance:
  brimonidine
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0255/2019
• PIP number:
  EMEA-002558-PIP01-19
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of conjunctival hyperaemia
• Route(s) of administration:
  Ophthalmic use
• Contact for public enquiries:

  Bausch Health Ireland Limited

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

• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  16/07/2019

Decision

P/0255/2019: EMA decision of 16 July 2019 on the refusal of a paediatric investigation plan and on the granting of a waiver for brimonidine (EMEA-002558-PIP01-19)

AdoptedReference Number: EMA/339076/2019