Vifor Fresenius Medical Care Renal Pharma (VFMCRP)
This sponsor has funded 2 studies across 7 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 11502 | Finalised | EU RMP category 3 | VERIFIE (Velphoro Evaluation of Real-lIfe saFety, effectIveness and adherencE): Non-interventional study to investigate the short- and long-term... | No | Yes |
| 105408 | Ongoing | EU RMP category 3 | Avacostar - A Post Authorization Safety Study (PASS) to Evaluate the Incidence of Safety Events of Interest in Patients Treated With Avacopan for... | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Vifor Fresenius Medical Care Renal Pharma (VFMCRP)
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
Vifor Fresenius Medical Care Renal Pharma (VFMCRP)
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
Vifor Fresenius Medical Care Renal Pharma (VFMCRP)
7 Study countries specified are the following:
- France
- Germany
- Greece
- Italy
- Netherlands
- Spain
- United Kingdom