EMEA-002817-PIP05-23 - paediatric investigation plan

Faricimab

Key facts

• Invented name:
  Vabysmo
• Active substance:
  Faricimab
• Therapeutic area:
  Eye disorders
• Decision number:
  P/0006/2024
• PIP number:
  EMEA-002817-PIP05-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of choroidal neovascularisation secondary to pathologic myopia
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/01/2024
• Compliance check done:
  Ne

Decision

P/0006/2024 : EMA decision of 12 January 2024 on the granting of a product-specific waiver for faricimab (Vabysmo), (EMEA-002817-PIP05-23)

Adopted Reference Number: EMA/8520/2024