Sanofi Pasteur MSD
This sponsor has funded 2 studies across 6 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 6536 | Finalised | EU RMP category 3 | Estimation of Background Incidence Rates of Guillain-Barré Syndrome in Germany in the years 2007-2009 (BIGS) | No | No |
| 13766 | Finalised | Not included in RMP | Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of... | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Sanofi Pasteur MSD
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
Sanofi Pasteur MSD
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
Sanofi Pasteur MSD
6 Study countries specified are the following:
- Denmark
- Germany
- Italy
- Netherlands
- Spain
- Sweden