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
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  16/07/2019
• Compliance check done:
  No

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)

Adopted Reference Number: EMA/339076/2019