EMEA-000471-PIP01-08-M02 - paediatric investigation plan

sitagliptin phosphate monohydrate

Key facts

• Invented name:
  • Xelevia
  • Xelevia
• Active substance:
  sitagliptin phosphate monohydrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0128/2016
• PIP number:
  EMEA-000471-PIP01-08-M02
• 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:
  21/05/2016
• Compliance check done:
  Ei

Decision

P/0128/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (phosphate monohydrate) (Xelevia) (EMEA-000471-PIP01-08-M02)

Adopted Reference Number: EMA/295715/2016