Ultragenyx
This sponsor has funded 2 studies across 10 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 25082 | Ongoing | EU RMP category 2 | Mucopolysaccharidosis VII Disease Monitoring Program (MPS VII DMP) | No | No |
| 47088 | Planned | EU RMP category 2 | An observational study to evaluate the long-term effects of evinacumab treatment in patients with homozygous familial hypercholesterolemia (HoFH) | No | No |
PAS by Risk Management Plan (RMP) requirement
Ultragenyx
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
Ultragenyx
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
Ultragenyx
10 Study countries specified are the following:
- Argentina
- Brazil
- France
- Germany
- Italy
- Netherlands
- Portugal
- Spain
- United Kingdom
- United States