EMEA-001533-PIP01-13-M02 - paediatric investigation plan

Ertugliflozin

Key facts

• Invented name:
  • Steglatro
  • Steglatro
• Active Substance:
  Ertugliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0141/2019
• PIP number:
  EMEA-001533-PIP01-13-M02
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Sharp and Dohme (Europe), Inc.

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/04/2019

Decision

P/0141/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for ertugliflozin (Steglatro), (EMEA-001533-PIP01-13-M02)

AdoptedReference Number: EMA/215044/2019