EMEA-000200-PIP01-08-M10 - paediatric investigation plan

saxagliptin

Key facts

• Invented name:
  • Onglyza
  • Onglyza
• Active substance:
  saxagliptin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0478/2022
• PIP number:
  EMEA-000200-PIP01-08-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:
  02/12/2022
• Compliance check done:
  Да
• Compliance procedure number:
  EMEA-C-000200-PIP01-08-M10
• Compliance opinion date:
  21/07/2023
• Compliance outcome:
  Positive

Decision

P/0478/2022: EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for saxagliptin (Onglyza), (EMEA-000200-PIP01-08-M10)

Adopted Reference Number: EMA/899035/2022