EMEA-000828-PIP05-17 - paediatric investigation plan

empagliflozin

Key facts

• Invented name:
  • Jardiance
  • Jardiance
• Active substance:
  empagliflozin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0216/2017
• PIP number:
  EMEA-000828-PIP05-17
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of cardiovascular events in patients with chronic 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:
  09/08/2017
• Compliance check done:
  Ne

Decision

P/0216/2017: EMA decision of 9 August 2017 on the granting of a product specific waiver for empagliflozin (Jardiance), (EMEA-000828-PIP05-17)

Adopted Reference Number: EMA/431236/2017