EMEA-003120-PIP01-21 - paediatric investigation plan

dapagliflozin

2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)

Key facts

• Active substance:
  • dapagliflozin
  • 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0063/2022
• PIP number:
  EMEA-003120-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Prevention of cardiovascular events in patients with chronic heart failure
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/03/2022
• Compliance check done:
  No

Decision

P/0063/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for dapagliflozin / 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro- 2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro- 2H-1,4-benzoxazin-3-yl}.....(AZD9977) (EMEA-003120-PIP01-21)

Adopted Reference Number: EMA/67591/2022