EMEA-001030-PIP01-10-M10 - paediatric investigation plan

canagliflozin

Key facts

• Invented name:
  Invokana
• Active substance:
  canagliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0208/2022
• PIP number:
  EMEA-001030-PIP01-10-M10
• Pharmaceutical form(s):
  Film-coated 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:
  10/06/2022
• Compliance check done:
  Sim
• Compliance procedure number:
  EMEA-C-001030-PIP01-10-M10
• Compliance opinion date:
  26/04/2024
• Compliance outcome:
  Positive

Decision

P/0208/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana), (EMEA-001030-PIP01-10-M10)

Adopted Reference Number: EMA/365808/2022