Orion Corporation
This sponsor has funded 3 studies across 5 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 2612 | Finalised | EU RMP category 3 | The risk of developing prostate cancer in entacapone and levodopa/DDCI users compared to levodopa/DDCI users without entacapone - A nation-wide... | No | Yes |
| 3243 | Finalised | EU RMP category 3 | A multinational, observational study to investigate the use of dexmedetomidine (dexdor®) in clinical practice (DEXDUS) | Yes | No |
| 7037 | Finalised | Not included in RMP | A retrospective, observational study to investigate the therapeutic value of dexmedetomidine (dexdor®) in clinical practice (DexBOS) | No | No |
PAS by Risk Management Plan (RMP) requirement
Orion Corporation
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
Orion Corporation
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
Orion Corporation
5 Study countries specified are the following:
- Austria
- Belgium
- Finland
- Germany
- Poland