EMEA-000828-PIP06-18 - paediatric investigation plan

empagliflozin

Key facts

• Invented name:
  Jardiance
• Active substance:
  empagliflozin
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0082/2019
• PIP number:
  EMEA-000828-PIP06-18
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of chronic kidney disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/03/2019
• Compliance check done:
  No

Decision

P/0082/2019: EMA decision of 22 March 2019 on the granting of a product specific waiver for empagliflozin (Jardiance), (EMEA-000828-PIP06-18)

Adopted Reference Number: EMA/122311/2019