MHRA-101513-PIP01-24-M02 (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
  • Steglatro
  • Steglatro
PIP Number MHRA-101513-PIP01-24-M02 (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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-101513-PIP01-24-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ERTUGLIFLOZIN L-PYROGLUTAMIC ACID.pdf
Published Date 01/05/2026