EMA/PE/0000230006 - paediatric investigation plan

empagliflozin / sitagliptin

Key facts

• Active substance:
  empagliflozin / sitagliptin
• Therapeutic area:
  Endocrine disorders
• Decision number:
  EMA/PE/0000230006
• PIP number:
  EMA/PE/0000230006
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of type 2 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:
  21/03/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000230006 : EMA decision of 21 March 2025 on the granting of a product specific waiver for empagliflozin / sitagliptin

Adopted Reference Number: EMADOC-1700519818-1978092