PMDAapproval83% confidence
[SHINSA]List of Approved Drugs: April 2004 to February 2026
Source: PMDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (cardiology) as AstraZeneca.
Regulatory Analysis
PMDA regulatory document relevant to this signal.
Supporting Context
- Therapeutic area
- Cardiology · Heart Failure
- Sub-indication
- Hypertension
Related signal: AstraZeneca's Dapagliflozin Approved for Heart Failure; Real-World Study Launched in Germany