Saxagliptin / metformin - paediatric investigation plan

Saxagliptin

Metformin

Key facts

• Active Substance:
  • Saxagliptin
  • Metformin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/240/2009
• PIP number:
  Saxagliptin / metformin
• 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:
  01/12/2009

Decision

P/240/2009: EMA decision of 1 December 2009 on the granting of a product specific waiver for saxagliptin / metformin (EMEA-000644-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the Eu...

AdoptedReference Number: EMEA/757733/2009