Sponsor unspecified
This sponsor has funded 3 studies across 6 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 16014 | Finalised | Not included in RMP | Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral... | Yes | Yes |
| 17302 | Finalised | Not included in RMP | How pregnant women perceive risk related to Congenital Rubella Syndrome: a prospective study conducted at University “Federico II” of Naples | Yes | Yes |
| 38060 | Planned | Not included in RMP | Drug-drug interactions between dicloxacillin/flucloxacillin and DOACs | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Sponsor unspecified
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
Sponsor unspecified
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
Sponsor unspecified
6 Study countries specified are the following:
- Denmark
- France
- Germany
- Italy
- Netherlands
- Spain