EMEA-000828-PIP01-09-M09 - paediatric investigation plan

empagliflozin

Key facts

• Invented name:
  • Jardiance
  • Jardiance
• Active Substance:
  empagliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0283/2021
• PIP number:
  EMEA-000828-PIP01-09-M09
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Boehringer Ingelheim International GmbH

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/10/2021
• Compliance procedure number:
  EMEA-C-000828-PIP01-09-M09
• Compliance opinion date:
  16/12/2022
• Compliance outcome:
  Positive

Decision

P/0283/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for empagliflozin (Jardiance) (EMEA-000828-PIP01-09-M09)

AdoptedReference Number: EMA/568637/2021