EMEA-000694-PIP06-20 - paediatric investigation plan

dapagliflozin

Key facts

• Invented name:
  Forxiga
• Active substance:
  dapagliflozin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0515/2020
• PIP number:
  EMEA-000694-PIP06-20
• 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:
  22/12/2020
• Compliance check done:
  Nu

Decision

P/0515/2020 : EMA decision of 22 December 2020 on the granting of a product specific waiver for dapagliflozin (forxiga) (EMEA-000694-PIP06-20)

Adopted Reference Number: EMA/631966/2020