Government of Navarre
This sponsor has funded 4 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 12083 | Finalised | NESTED CASE-CONTROL STUDY TO ASSESS THE ASSOCIATION BETWEEN THE USE OF METHYLPHENIDATE AND THE RISK OF VALVULAR HEART DISEASE AND PULMONARY... | Yes | No |
| 35832 | Planned | Effect of the “Triple whammy” in hospitalization due to acute kidney injury: a case-control study nested in a cohort | No | No |
| 103472 | Planned | Net clinical benefit of vitamin K antagonists versus direct oral anticoagulants for nonvalvular atrial fibrillation | Yes | No |
| 104667 | Planned | Does metamizole cause less kidney injury than non-steroidal anti-inflammatory drugs when administered in combination with diuretics and... | No | No |
PAS by Risk Management Plan (RMP) requirement
Government of Navarre
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
Government of Navarre
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
Government of Navarre
1 Study countries specified are the following:
- Spain