EMEA-003114-PIP01-21 - paediatric investigation plan
Efruxifermin
PIPHuman
Key facts
Active Substance
Efruxifermin
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0302/2022
PIP number
EMEA-003114-PIP01-21
Pharmaceutical form(s)
Powder for solution for injection
Condition(s) / indication(s)
Treatment of non-alcoholic steatohepatitis (NASH)
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Decision
P/0302/2022: EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efruxifermin (EMEA-003114-PIP01-21)