LFB Biotechnologies
This sponsor has funded 2 studies across 8 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 105020 | Ongoing | Eptacog beta post marketing safety surveillance using aggregated data reports from the EUHASS Registry (F7TG2206-EUHASS Registry) | No | No |
| 105707 | Ongoing | Eptacog Beta post marketing safety surveillance using the PedNet registry (F7TG2207 – PedNet Registry) | No | No |
PAS by Risk Management Plan (RMP) requirement
LFB Biotechnologies
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
LFB Biotechnologies
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
LFB Biotechnologies
8 Study countries specified are the following:
- Austria
- Belgium
- France
- Germany
- Italy
- Netherlands
- Spain
- United Kingdom