EMEA-000694-PIP04-18 - paediatric investigation plan

dapagliflozin

Key facts

• Invented name:
  • Forxiga
  • Forxiga
• Active substance:
  dapagliflozin
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0373/2018
• PIP number:
  EMEA-000694-PIP04-18
• 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:
  07/12/2018
• Compliance check done:
  Nein

Decision

P/0373/2018: EMA decision of 7 December 2018 on the granting of a product-specific waiver for dapagliflozin (Forxiga), (EMEA-000694-PIP04-18)

Adopted Reference Number: EMA/797210/2018