Zambon
This sponsor has funded 3 studies across 6 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 13745 | Finalised | EU RMP category 3 | European multicenter retrospective-prospective cohort study to observe Safinamide safety profile and pattern of use in clinical practice during the... | Yes | Yes |
| 20021 | Ongoing | Not included in RMP | NIS Xtra (Verträglichkeit und Wirksamkeit von Safinamid) | No | No |
| 41248 | Ongoing | Not included in RMP | AN OBSERVATIONAL, PROSPECTIVE, MULTINATIONAL, MULTICENTRE STUDY COMPARING THE EFFECTIVENESS OF SAFINAMIDE, RASAGILINE AND OTHER “STANDARD OF CARE” AS... | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Zambon
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
Zambon
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
Zambon
6 Study countries specified are the following:
- Belgium
- Germany
- Italy
- Spain
- Switzerland
- United Kingdom