MHRA-101513-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
Invented Name
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
PIP Number MHRA-101513-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of Type 2 Diabetes Mellitus
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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):ERTUGLIFLOZIN L-PYROGLUTAMIC ACID.pdf
Published Date 03/10/2024