Zogenix
This sponsor has funded 3 studies across 10 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 32984 | Planned | Not included in RMP | A European non-interventional study to understand the criteria used and the time required for the clinical diagnosis in participants with refractory... | No | No |
| 48741 | Ongoing | EU RMP category 3 | A European Study of the Effectiveness of Risk Minimisation Measures for Fenfluramine in Dravet Syndrome (TAPESTRY eRMM) | No | No |
| 105358 | Ongoing | EU RMP category 1 | A Registry of Patients Treated with Fintepla (TAPESTRY Registry) | No | No |
PAS by Risk Management Plan (RMP) requirement
Zogenix
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
Zogenix
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
Zogenix
10 Study countries specified are the following:
- Austria
- Belgium
- Denmark
- France
- Germany
- Ireland
- Italy
- Spain
- Sweden
- United Kingdom