Leadiant Biosciences
This sponsor has funded 4 studies across 7 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 6929 | Finalised | Pregnancy Registry for Eurartesim | Yes | Yes |
| 6942 | Finalised | Safety registry for Eurartesim | Yes | Yes |
| 8304 | Finalised | Effectiveness evaluation survey for Eurartesim | Yes | Yes |
| 27028 | Ongoing | Title Cerebrotendinous Xanthomatosis Registry: Long term Non-Interventional Follow-up of Safety and Effectiveness of Chenodeoxycholic Acid Leadiant. | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Leadiant Biosciences
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
Leadiant Biosciences
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
Leadiant Biosciences
7 Study countries specified are the following:
- Belgium
- France
- Germany
- Italy
- Netherlands
- Spain
- United Kingdom