MHRA-100512-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • DAPAGLIFLOZIN
Invented Name
  • Forxiga
  • Forxiga
PIP Number MHRA-100512-PIP01-22-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 1 Diabetes Mellitus
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(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):DAPAGLIFLOZIN.pdf
Published Date 30/01/2024