EMEA-000828-PIP07-21 - paediatric investigation plan

empagliflozin

Key facts

• Invented name:
  Jardiance
• Active substance:
  empagliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0306/2021
• PIP number:
  EMEA-000828-PIP07-21
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of ischaemic heart 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:
  14/09/2021
• Compliance check done:
  Ei

Decision

P/0306/2021 : EMA decision of 14 September 2021 on the granting of a product specific waiver for empagliflozin (Jardiance), (EMEA-000828-PIP07-21)

Adopted Reference Number: EMA/517346/2021