MHRA-100271-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • LINAGLIPTIN
Invented Name
  • Trajenta
  • Trajenta
PIP Number MHRA-100271-PIP01-21-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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100271-PIP01-21-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LINAGLIPTIN.pdf
Published Date 02/02/2023