Institut de Recherches International Servier (IRIS)
This sponsor has funded 2 studies across 5 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 17678 | Finalised | Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation... | Yes | No |
| 44583 | Ongoing | Effectiveness of Indapamide SR on top of Perindopril on blood pressure change: a methodological study to validate effect of anti-hypertensive drugs in... | No | No |
PAS by Risk Management Plan (RMP) requirement
Institut de Recherches International Servier (IRIS)
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
Institut de Recherches International Servier (IRIS)
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
Institut de Recherches International Servier (IRIS)
5 Study countries specified are the following:
- Denmark
- France
- Germany
- Spain
- United Kingdom