EMEA-001517-PIP02-14-M03 - paediatric investigation plan

sotagliflozin

Key facts

• Invented name:
  Zynquista
• Active substance:
  sotagliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0226/2021
• PIP number:
  EMEA-001517-PIP02-14-M03
• Pharmaceutical form(s):
  • Granules
  • Film-coated tablet
• 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:
  08/06/2021
• Compliance check done:
  Ne

Decision

P/0226/2021 : EMA decision of 8 June 2021 on the acceptance of a modification of an agreed paediatric investigation plan for sotagliflozin (Zynquista) (EMEA-001517-PIP02-14-M03)

Adopted Reference Number: EMA/235313/2021 corr