EMEA-000694-PIP05-20 - paediatric investigation plan

dapagliflozin

Key facts

• Invented name:
  Forxiga
• Active Substance:
  dapagliflozin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0444/2020
• PIP number:
  EMEA-000694-PIP05-20
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AstraZeneca AB

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2020

Decision

P/0444/2020: EMA decision of 1 December 2020 on the granting of a product specific waiver for dapagliflozin (Forxiga), (EMEA-000694-PIP05-20)

AdoptedReference Number: EMA/599228/2020 Corr