Sitagliptin phosphate monohydrate, metformin hydrochloride - paediatric investigation plan

sitagliptin phosphate monohydrate

metformin hydrochloride

Key facts

• Invented name:
  • Janumet
  • Janumet
• Active substance:
  • sitagliptin phosphate monohydrate
  • metformin hydrochloride
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/114/2008
• PIP number:
  Sitagliptin phosphate monohydrate, metformin hydrochloride
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2008
• Compliance check done:
  No

Decision

P/114/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for sitagliptin phosphate monohydrate, metformin hydrochloride (Janumet) EMEA-000165-...

Adopted Reference Number: EMEA/625238/2008