MEDICE Health Family
This sponsor has funded 3 studies across 10 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 7778 | Finalised | Drug utilization study of dexamfetamine in European countries (DUS of dexamfetamine) | Yes | Yes |
| 7782 | Finalised | Post-authorisation Safety Study to Evaluate the Long-term Safety of Dexamfetamine (Amfexa) (PASS for dexamfetamine) | Yes | Yes |
| 39745 | Planned | A post-authorisation safety study (PASS) to evaluate the long-term cardiovascular and psychiatric safety profile of methylphenidate (MPH) in adult... | No | No |
PAS by Risk Management Plan (RMP) requirement
MEDICE Health Family
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
MEDICE Health Family
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
MEDICE Health Family
10 Study countries specified are the following:
- Denmark
- Finland
- Germany
- Ireland
- Netherlands
- Norway
- Spain
- Sweden
- United Kingdom
- United States