P/93/2010 - paediatric investigation plan

sitagliptin phosphate monohydrate

metformin hydrochloride

Key facts

• Invented name:
  Janumet and associated names
• Active Substance:
  • sitagliptin phosphate monohydrate
  • metformin hydrochloride
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/93/2010
• PIP number:
  P/93/2010
• Pharmaceutical form(s):
  • Film-coated tablet
  • Modified-release tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Sharp & 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:
  02/06/2010

Decision

P/93/2010: European Medicines Agency decision of 2 June 2010 on the granting of a product specific waiver for sitagliptin phosphate monohydrate / metformin hydrochloride (Janumet and associated names) (EMEA-000165-PIP02-...

AdoptedReference Number: EMA/337455/2010