EMEA-000496-PIP01-08-M08 - paediatric investigation plan

alogliptin

Key facts

• Invented name:
  Vipidia
• Active substance:
  alogliptin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0257/2020
• PIP number:
  EMEA-000496-PIP01-08-M08
• 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:
  15/07/2020
• Compliance check done:
  Да
• Compliance procedure number:
  EMEA-C-000496-PIP01-08-M08
• Compliance opinion date:
  11/11/2022
• Compliance outcome:
  Positive

Decision

P/0257/2020 : EMA decision of 15 July 2020 on the acceptance of a modification of an agreed paediatric investigation plan for alogliptin (Vipidia) (EMEA-000496-PIP01-08-M08)

Adopted Reference Number: EMA/315644/2020