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
Contact for public enquiries

Bristol-Myers Squibb International Corporation

Tel. +44 1895523740
E-mail: medical.information@bms.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

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)

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