CSL Vifor
This sponsor has funded 3 studies across 28 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 25192 | Finalised | Severe hypersensitivity reactions associated with high dose iv iron containing medicinal products | No | Yes |
| 27963 | Finalised | Severe hypersensitivity reactions associated with i.v. iron containing medicinal products in countries of the European Economic Area – before and... | No | Yes |
| 43542 | Ongoing | Comparison of outcomes in patients undergoing major planned surgeries before vs. after the implementation of Patient Blood Management (PBM): a... | No | No |
PAS by Risk Management Plan (RMP) requirement
CSL Vifor
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
CSL Vifor
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
CSL Vifor
28 Study countries specified are the following:
- Austria
- Belgium
- Bulgaria
- Croatia
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Lithuania
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Switzerland
- United Kingdom