MHRAapproval83% confidence
Clinical trials for medicines: modifying a clinical trial approval
Source: MHRA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (cardiology) as Teva.
Regulatory Analysis
Guidance on the various types of modifications that can be made to a clinical trial approval.
Supporting Context
- Therapeutic area
- Cardiology · Pulmonary Arterial Hypertension
- Sub-indication
- Hypertension
Related signal: FDA Grants Approval for Macitentan ANDA211187 by Teva Pharmaceuticals