Orphan Europe
This sponsor has funded 1 studies across 5 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 11209 | Finalised | Registry of Pediatric Patients Treated with Vedrop® (Tocofersolan) in Europe for Vitamin E Deficiency due to Digestive Malabsorption in Congenital or... | No | Yes |
PAS by Risk Management Plan (RMP) requirement
Orphan Europe
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
Orphan Europe
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
Orphan Europe
5 Study countries specified are the following:
- France
- Germany
- Netherlands
- Spain
- Sweden