EMEA-001532-PIP01-13 - paediatric investigation plan

Ertugliflozin

Metformin

Key facts

• Active substance:
  • Ertugliflozin
  • Metformin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0054/2014
• PIP number:
  EMEA-001532-PIP01-13
• Pharmaceutical form(s):
  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:
  07/03/2014
• Compliance check done:
  No

Decision

P/0054/2014: European Medicines Agency decision of 7 March 2014 on the granting of a product specific waiver for ertugliflozin / metformin (EMEA-001532-PIP01-13)

Adopted Reference Number: EMA/58700/2014