MHRA-100809-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Efruxifermin
Invented Name
Not available at present
PIP Number MHRA-100809-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for injection
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of non-alcoholic steatohepatitis (NASH)
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Efruxifermin.pdf
Published Date 19/12/2023