EMEA-003486-PIP01-23 - paediatric investigation plan

sitagliptin

dapagliflozin

Key facts

• Active substance:
  • sitagliptin
  • dapagliflozin
• Therapeutic area:
  Endocrine disorders
• Decision number:
  P/0539/2023
• PIP number:
  EMEA-003486-PIP01-23
• Pharmaceutical form(s):
  Film-coated 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:
  29/12/2023
• Compliance check done:
  No

Decision

P/0539/2023: EMA decision of 29 December 2023 on the granting of a product specific waiver for sitagliptin / dapagliflozin (EMEA-003486-PIP01-23)

Reference Number: EMA/562282/2023