EMEA-000470-PIP01-08-M11 - paediatric investigation plan

sitagliptin

Key facts

• Invented name:
  Januvia
• Active substance:
  sitagliptin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0358/2019
• PIP number:
  EMEA-000470-PIP01-08-M11
• 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:
  04/10/2019
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000470-PIP01-08-M11
• Compliance opinion date:
  28/02/2020
• Compliance outcome:
  Positive

Decision

P/0358/2019: EMA decision of 4 October 2019 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (Januvia (and associated names)), (EMEA-000470-PIP01-08-M11)

Adopted Reference Number: EMA/523992/2019