MHRA-100039-PIP01-21-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Cotadutide
Invented Name
Not yet available
PIP Number MHRA-100039-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • 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
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
13/12/2021
Compliance Check Procedure Number
Compliance procedure number
MHRA-100039-PIP01-21-M01-C1

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Cotadutide.pdf
Published Date 17/12/2021