Innovationsausschuss
This sponsor has funded 2 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 31559 | Finalised | Observational study on the risk of myocardial infarction and stroke associated with proton pump inhibitor use (RiDe-PPI (MI & STROKE)) | Yes | No |
| 31571 | Finalised | Observational study on the risk of dementia associated with proton pump inhibitor use | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Innovationsausschuss
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
Innovationsausschuss
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
Innovationsausschuss
1 Study countries specified are the following:
- Germany