EMEA-001841-PIP01-15 - paediatric investigation plan

bexagliflozin

Key facts

• Active substance:
  bexagliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0164/2016
• PIP number:
  EMEA-001841-PIP01-15
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/06/2016
• Compliance check done:
  No

Decision

P/0164/2016: EMA decision of 15 June 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bexagliflozin (EMEA-001841-PIP01-15)

Adopted Reference Number: EMA/336929/2016