EMEA-000236-PIP04-14 - paediatric investigation plan

aflibercept

Key facts

• Invented name:
  • Eylea
  • Eylea
• Active substance:
  aflibercept
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0165/2014
• PIP number:
  EMEA-000236-PIP04-14
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of choroidal neovascularisation secondary to pathologic myopia
  • Treatment of branch retinal vein occlusion
• Route(s) of administration:
  Solution for injection
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/06/2014
• Compliance check done:
  Non

Decision

P/0165/2014: EMA decision of 27 June 2014 on the granting of a product specific waiver for aflibercept (Eylea), (EMEA-000236-PIP04-14)

Adopted Reference Number: EMA/356633/2014