Sitagliptin phosphate monohydrate, metformin hydrochloride - paediatric investigation plan

sitagliptin phosphate monohydrate

metformin hydrochloride

Key facts

• Invented name:
  • Efficib
  • Efficib
• Active Substance:
  • sitagliptin phosphate monohydrate
  • metformin hydrochloride
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/117/2008
• 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
• Contact for public enquiries:

  Merck Sharp and Dohme (Europe), Inc.

  Belgium; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2008

Decision

P/117/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for sitagliptin phosphate monohydrate, metformin hydrochloride (Efficib) EMEA-000213-...

AdoptedReference Number: EMEA/625237/2008