EMEA-000703-PIP01-09 - paediatric investigation plan

vildagliptin

metformin hydrochloride

Key facts

• Invented name:
  Eucreas
• Active Substance:
  • vildagliptin
  • metformin hydrochloride
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/169/2010
• PIP number:
  EMEA-000703-PIP01-09
• 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:
  03/09/2010

Decision

P/169/2010: European Medicines Agency decision of 3 September 2010 on the granting of a product specific waiver for vildagliptin / metformin hydrochloride (Eucreas), (EMEA-000703-PIP01-09)

AdoptedReference Number: EMA/477499/2010