Alcon
This sponsor has funded 4 studies across 10 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 4554 | Finalised | Not included in RMP | INJECT: Investigation of JETREA® in patients with confirmed vitreo-macular traction | No | No |
| 4796 | Finalised | EU RMP category 3 | Use of Intravitreal JETREA in Clinical Practice: A European Prospective Drug Utilisation Study (TG-MV-017) (TULIP) | No | Yes |
| 5278 | Finalised | EU RMP category 3 | Evaluation of the Use of Nepafenac in Selected European Populations | Yes | No |
| 5584 | Finalised | Not included in RMP | Post-market clinical follow-up study – Retrospective evaluation of endothelial cell density and IOL explants related to the clinical use of AcrySof®... | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Alcon
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
Alcon
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
Alcon
10 Study countries specified are the following:
- Canada
- Denmark
- France
- Germany
- Italy
- Netherlands
- Norway
- Portugal
- Spain
- United Kingdom