EMEA-001533-PIP01-13-M03 - paediatric investigation plan

Ertugliflozin

Key facts

• Invented name:
  Steglatro
• Active Substance:
  Ertugliflozin
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0189/2024
• PIP number:
  EMEA-001533-PIP01-13-M03
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2024

Decision

P/0189/2024 - EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ertugliflozin (Steglatro), (EMEA-001533-PIP01-13-M03)

AdoptedReference Number: EMA/251732/2024