EMEA-002448-PIP01-18-M02 - paediatric investigation plan

pegylated-fibroblast growth factor 21 (BMS-986036)

Key facts

• Active substance:
  pegylated-fibroblast growth factor 21 (BMS-986036)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0346/2021
• PIP number:
  EMEA-002448-PIP01-18-M02
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/08/2021
• Compliance check done:
  No

Decision

P/0346/2021 : EMA decision of 18 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for pegylated-fibroblast growth factor 21 (BMS-986036) (EMEA-002488-PIP01-18-M02)

Adopted Reference Number: EMA/451036/2021