EMEA-000828-PIP04-16-M03 - paediatric investigation plan

empagliflozin

Key facts

• Invented name:
  Jardiance
• Active substance:
  empagliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0345/2019
• PIP number:
  EMEA-000828-PIP04-16-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate dosage form, other
• 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:
  11/09/2019
• Compliance check done:
  Ne

Decision

P/0345/2019: EMA decision of 11 September 2019 on the acceptance of a modification of an agreed paediatric investigation plan for empagliflozin (Jardiance), (EMEA-000828-PIP04-16-M03)

Adopted Reference Number: EMA/439200/2019