EMEA-003632-PIP01-24 - paediatric investigation plan

Empagliflozin / Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one (BI 690517)

Key facts

• Active substance:
  Empagliflozin / Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one (BI 690517)
• Therapeutic area:
  Cardiac disorders
• Decision number:
  P/0326/2024
• PIP number:
  EMEA-003632-PIP01-24
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of heart failure
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0326/2024 : EMA decision of 13 September 2025 on the granting of a product specific waiver for empagliflozin / derivative of 3‐phenyl‐3H,4H,6H,7Hpyrano[ 3,4‐d]imidazol‐4‐one (BI 690517), (EMEA-003632-PIP01-24)

Adopted Reference Number: EMA/413681/2024