EMEA-001517-PIP01-13-M01 - paediatric investigation plan

sotagliflozin

Key facts

• Active substance:
  sotagliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0210/2017
• PIP number:
  EMEA-001517-PIP01-13-M01
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/08/2017
• Compliance check done:
  No

Decision

P/0210/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sotagliflozin (EMEA- 001517-PIP01-13-M01)

Adopted Reference Number: EMA/430899/2017