Orexigen Therapeutics
This sponsor has funded 2 studies across 7 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 103743 | Planned | EU RMP category 3 | DRUG UTILISATION AND SAFETY STUDY OF MYSIMBA/CONTRAVE IN EUROPE AND THE UNITED STATES (NB-451 DUS) | No | No |
| 103748 | Finalised | EU RMP category 3 | Effectiveness of the Mysimba Physician Prescribing Checklist (PPC): Focus group to assess understanding, attitude, and behaviour for usage of the PPC... | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Orexigen Therapeutics
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
Orexigen Therapeutics
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
Orexigen Therapeutics
7 Study countries specified are the following:
- Czechia
- Denmark
- Finland
- Greece
- Norway
- Sweden
- United States