Clinuvel
This sponsor has funded 3 studies across 7 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 13001 | Ongoing | A Post-Authorisation Disease Registry Safety Study to Generate Data on the Long-Term Safety and Clinical Effectiveness of SCENESSE® (Afamelanotide... | No | No |
| 13004 | Ongoing | Protocol version for countries where patients treated off-label cannot be included in the disease registry: A Post-Authorisation Disease Registry... | No | No |
| 13350 | Planned | SCENESSE® (Afamelanotide 16mg) Retrospective Chart Review (SCENESSE® Chart Review) | No | No |
PAS by Risk Management Plan (RMP) requirement
Clinuvel
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
Clinuvel
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
Clinuvel
7 Study countries specified are the following:
- Austria
- Finland
- Germany
- Italy
- Netherlands
- Slovenia
- United Kingdom