EMEA-000498-PIP01-08-M10 - paediatric investigation plan

linagliptin

Key facts

• Invented name:
  • Trajenta
  • Trajenta
• Active substance:
  linagliptin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0446/2021
• PIP number:
  EMEA-000498-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:
  29/10/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000498-PIP01-08-M10
• Compliance opinion date:
  16/12/2022
• Compliance outcome:
  Positive

Decision

P/0446/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta) (EMEA-000498-PIP01-08-M10)

Adopted Reference Number: EMA/534672/2021