Sanofi US
This sponsor has funded 2 studies across 8 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 18129 | Finalised | Serious Liver Injury and Interstitial Lung Disease Occurrences in Patients Diagnosed with Atrial Fibrillation Treated with Selected Antiarrhythmics | Yes | Yes |
| 47940 | Planned | Cold Agglutinin Disease Real World Evidence Registry (Cadence) | No | No |
PAS by Risk Management Plan (RMP) requirement
Sanofi US
The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.
Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.
PAS by study status
Sanofi US
The study status is defined according to the timeline dates specified.
Planned studies have not collected any data yet.
Ongoing studies collect data and should publish protocols as soon as possible.
Finalised studies should publish results in the first two weeks after finalisation.
Countries
Sanofi US
8 Study countries specified are the following:
- Austria
- France
- Germany
- Italy
- Japan
- Spain
- United Kingdom
- United States