EMEA-000694-PIP03-17 - paediatric investigation plan

dapagliflozin

Key facts

• Invented name:
  • Forxiga
  • Forxiga
• Active substance:
  dapagliflozin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0202/2018
• PIP number:
  EMEA-000694-PIP03-17
• 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:
  19/07/2018
• Compliance check done:
  Ne

Decision

P/0202/2018: EMA decision of 19 July 2018 on the granting of a product-specific waiver for dapagliflozin (Forxiga), (EMEA-000694-PIP03-17)

Adopted Reference Number: EMA/421228/2018