EMEA-000694-PIP02-14-M03 - paediatric investigation plan

dapagliflozin

Key facts

• Invented name:
  • Forxiga
  • Forxiga
• Active substance:
  dapagliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0161/2022
• PIP number:
  EMEA-000694-PIP02-14-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral dosage formulation
• Condition(s) / indication(s):
  Treatment of type I diabetes mellitus
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022
• Compliance check done:
  Nej

Decision

P/0161/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP02-14-M03)

Adopted Reference Number: EMA/169194/2022