Sitagliptin (phosphate monohydrate) - paediatric investigation plan

sitagliptin phosphate monohydrate

Key facts

• Invented name:
  • Tesavel
  • Tesavel
• Active Substance:
  sitagliptin phosphate monohydrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0129/2016
• PIP number:
  Sitagliptin (phosphate monohydrate)
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/05/2016

Decision

P/0129/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (phosphate monohydrate) (TESAVEL) EMEA-000472-PIP01-08-M02)

AdoptedReference Number: EMA/295716/2016