EMEA-003253-PIP01-22-M01 - paediatric investigation plan

Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3 (SAR442501)

Key facts

• Active substance:
  Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3 (SAR442501)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0304/2024
• PIP number:
  EMEA-003253-PIP01-22-M01
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of achondroplasia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/08/2024
• Compliance check done:
  No

Decision

P/0304/2024 : EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for humanised monoclonal antibody derivative against fibroblast growth factor receptor 3 (SAR442501) (EMEA- 003253-PIP01-22-M01)

Adopted Reference Number: EMA/364885/2024