EMEA-000236-PIP05-18 - paediatric investigation plan

aflibercept

Key facts

• Invented name:
  Eylea
• Active substance:
  aflibercept
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0115/2019
• PIP number:
  EMEA-000236-PIP05-18
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of retinopathy of prematurity
• Route(s) of administration:
  Intravitreal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  04/04/2019
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000236-PIP05-18
• Compliance opinion date:
  15/10/2021
• Compliance outcome:
  Positive

Decision

P/0115/2019: EMA decision of 4 April 2019 on the agreement of a paediatric investigation plan and on the granting of a waiver for aflibercept

Reference Number: EMA/182951/2019