P/3/2010 - paediatric investigation plan

linagliptin

metformin

Key facts

• Active Substance:
  • linagliptin
  • metformin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/3/2010
• PIP number:
  P/3/2010
• 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:
  25/01/2010

Decision

P/3/2010: European Medicines Agency decision on the granting of a product specific waiver for linagliptin, metformin (EMA-000699-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and o...

AdoptedReference Number: EMEA/38450/2010